Medical Supplies DPI COVID TEST ANTIPANDEMIC TECHNOLOGY VENTILATORS - 013 Industries
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COVID19
Medical Supplies
DPI
COVID TEST
ANTIPANDEMIC TECHNOLOGY
VENTILATORS
DPI Dispositivi di protezione individuale • MASK CHIRURGICHE N95/FFP2/FFP3/KN95
DPI Dispositivi di protezione individuale • MASK • TUTE DI PROTEZIONE • CAMICI CHIRURGICI • GUANTI
N95/N99/FFP2
N95/N99/FFP2
Page 1 of 6 Report No. TPGD20032623435
Certificate – Cертификат – 證明書 – Certificat – 증명서 – شهادة
Form QAT_10-M04, version 00, effective since March 6th, 2020
TECHNICAL CONSTRUCTION FILE
Page 1 of 6 Report No. TPGD20032623435 Certificate of Compliance
CERTIFICATION OF REGISTRATION Report Reference No....................... : TPGD20032623435
No. 0P200330E.DIP00079
Tested by (+ signature) .................... : Jessica CONSTRUCTION
TECHNICAL Meng FILE.....................................................
Note: Technical Construction File no. TPGD20032623435
This file is Not being issued by FDA. We, GTS, as the 3rd party, produce it, intended to Approved by (+ signature) ............... : Kevin Shi .....................................................
facilitate customer display & transmit information. The following contents, FDA registered
Facility/Owner/Operator&FDA listing Medical Device, are excerpted from database at Date of Reference
Report issue ....................................
No....................... :: Mar. 26, 2020
TPGD20032623435 Certificate’s Dongguan Ilda Protective Equipment
www.fda.gov.
Tested by (+ signature) .................... : Jessica Meng .....................................................
Holder: Co. Ltd
Establishment: Room 201, Building 2, No. 1, Xialang Changyuan
Testing Shanghai Global Testing Services Co., Ltd. Road, Qishi Town, Dongguan City, Guangdong
Dongguan ilda protective equipment co. LTD ApprovedLaboratory ........................
by (+ signature) ............... :: Kevin Shi .....................................................
Room 201, building 2, No. 1, xialang changyuan road, qishi town, dongguan, Floor 2nd, Building D-1, No. 128, Shenfu Road, Minhang District, Province, China
Address............................................
Date of issue .................................... :: Mar. 26, 2020
guangdong,China 523000 Shanghai, China.
Registration Number / FEI Number*: Testing procedure ...................... : TL [×] TMP[ ] WMT[ ] Certification ECM
* Firm Establishment Identifier (FEI) should be used for identification of entities within the imports message set
Status: Active Testing Laboratory
Applicant’s ........................ :
name ........................... Dongguan ilda protective
Shanghai Global equipment
Testing Services co.Ltd.
Co., LTD Mark: European Type
Conformity Approved
Date of Registration Status: 2020 Floor
Room2nd,
201, Building D-1,
building 2, No.No. 128, Shenfu
1, xialang Road,road,
changyuan Minhang
qishi District,
town,
Address............................................ :
Shanghai, China.
dongguan city, guangdong province,china
Owner/Operator Testing procedure ...................... : TL [×] TMP[ ] WMT[ ]
Dongguan ilda protective equipment co. LTD Test specification: Product: Daily protective masks (Not Sterile)
Room 201, building 2, No. 1, xialang changyuan road, qishi town, dongguan, Applicant’s name ........................... : Dongguan ilda protective equipment co. LTD
guangdong,China 523000 Standard........................................... : EN 149:2001+A1:2009 Model(s): 99_95A
Owner/Operator Number: 10066222 Address............................................ : Room 201, building 2, No. 1, xialang changyuan road, qishi town,
Type of Test ................................... : PST[ ] city, guangdong province,china
dongguan Registration（type test） [×]
Verification to: Standard:
Official Correspondent Non-standard test method…………..:
Test specification: N/A EN 149: 2001+A1:2009
Contact Name: Chang Sheng Li Manager
Room 201, building 2, No. 1, xialang changyuan road, qishi town, dongguan, Manufacturer....................................
Standard........................................... :: Dongguan ilda protective equipment co. LTD
EN 149:2001+A1:2009 related to CE Directive(s):
guangdong,China 523000
Adress..............................................
Type of Test ................................... :: Room
PST[ 201,
] building 2, No. 1, xialang changyuan road,
Registration（type qishi[×]
test） town, R 2016/425 (Personal Protective Equipment)
Tel: +86- 769-86526958 E-mail: qtlcs369@163.com dongguan city, guangdong province,china
Remark: This document has been issued on a voluntary basis and upon request of the manufacturer. It is
Non-standard test method…………..: N/A our opinion that the technical documentation received from the manufacturer is satisfactory for the
Devices Listing Information Product name................................... : Daily protective masks requirements of the ECM Certification Mark. The conformity mark above can be affixed on the products
Product Device Listing Establishment Manufacturer.................................... : Dongguan ilda protective equipment co. LTD accordingly to the ECM regulation about its release and its use.
Proprietary Name Model No. ....................................... : KN95
Codes Class Number Operations Additional information and clarification about the Marking:
Adress.............................................. : Room 201, building 2, No. 1, xialang changyuan road, qishi town,
dongguan city, guangdong province,china The manufacturer is responsible for the CE Marking process, and if necessary, must
Daily Protective Mask LYU 1 D38**** Manufacturer refer to a Notified Body. This document has been issued on the basis of the regulation
Product name................................... : on ECM Voluntary Mark for the certification of products. RG01_ECM rev.3 available
Disposable Face Mask LYU 1 D38**** Manufacturer Daily protective masks at: www.entecerma.it
Please careful protect your Listing Number. Model No. ....................................... : KN95 Issuance date: 30 March 2020
Expiry date: 29 March 2025
Reviewer Approver
Technical expert ECM Service Director
Amanda Payne Luca Bedonni
Signature: ________________________
Professional FDA Registration Services, by Shanghai Global Testing Services Co., Ltd.
More details on the website: http://www.gts-lab.com
Need help? Contact us, GTS, at +86(021) 33637866 & info@gts-lab.com This document is issued subject to GTS CENERALCONDITIONS OF SERVICE,and shall not be reproduced except in full or with written approval by GTS Testing.
FDA CERTIFICATE NUM: GTS23545 Shanghai Global Testing Services Co., Ltd.
Floor 2nd, Building D-1, No. 128, Shenfu Road, Minhang District, Shanghai, China.
Tel: (86-21) 3363 7866 Fax: (86-21) 3363 7858 E-mail: info@gts-lab.com Web Site: http://www.gts-lab.com
Ente Certificazione Macchine Srl
Via Ca’ Bella, 243 – Loc. Castello di Serravalle – 40053 Valsamoggia (BO) - ITALY
+39 051 6705141 +39 051 6705156 info@entecerma.it www.entecerma.it
This document is issued subject to GTS CENERALCONDITIONS OF SERVICE,and shall not be reproduced except in full or with written approval by GTS Testing.
Shanghai Global Testing Services Co., Ltd.
Floor 2nd, Building D-1, No. 128, Shenfu Road, Minhang District, Shanghai, China.
Tel: (86-21) 3363 7866 Fax: (86-21) 3363 7858 E-mail: info@gts-lab.com Web Site: http://www.gts-lab.com
N95/FFP2 RIF B03
FFP3
FFP3
COVID19 Ventilators
Ventilatori
• CRIUSV6
Ventilation Modes
Technical Specification
VCV(A/C) PCV(A/C)
SIMV(PCV)+PSV SIMV(PRVC)+PSV
PRVC SIMV(VCV)+PSV
SPONT/CPAP+PSV
BIVENT+PSV NIV/CPAP NIV-T NIV-S/T
Parameters
Tidal Volume: 20~2000 ml
Respiration Rate: 1~80 bpm
Tinsp: 0.2~9 s
Tslope: 0~2 s
Tpause: 0~4 s
I:E Ratio: 1:10~4:1
FiO 2: 21%~100%
Trigger Sensitivity: Pressure (-20~0 cmH 2O, above PEEP)
Flow (0.5~20 LPM)
PEEP: 0~35 cmH 2O
Psupport: 0~70 cmH 2O
Pinsp: 5~70 cmH 2O
Special Procedures
Apnea Ventilation Smart Suction Manual Breath
Insp/ Exp Hold ETCO 2 Measurement
Nebulization Waveform Freeze
Monitoring
Pressure Value: Ppeak, Pplat, Pmean, Pmin, PEEP
Volume / Flow Value: Vti, Vte, MV, MVspont
Time Value: ftotal,fspont, I:E
Real Time Curves: Pressure-Time, Flow-Time, Volume-Time waveforms
Pressure-Volume, Volume-Flow, Flow-Pressure loops
Gas Monitoring: FiO 2, ETCO 2
Calculated Values: Compliance(C)
Resistance(R)
MVleak
RSBI
WOB
PEEPi
Alarm
• Disponibile in stock
Paw high / low MVe high / low Circuit disconnnect
FiO 2 high / low Inspiration / Expiratory tidal volume low
High Respiration Rate Apnea AC Failure Nebulizer On
Low Battery Air /O 2 supply down High / Low PEEP
Technical Data
Leakage out of range Occlusion
An Optimal Combination of Invasive and Noninvasive Ventilator
Screen: 12〞TFT color touch screen (detachable)
Supply Gas: O 2, 0.28~0.6 MPa
Power Supply: AC100~240 V, 50 Hz/60 Hz
Communication Interface: RS-232 Port, Nurse call Port, Ethernet PortVentilatori This invasive ICU Ventilator by Northern features fully electric controls & ventilation modes includes
spn-CPAP, PC-CMV, PC-ACV, PC-SIMV, PC Dual PAP, PC-AMV, PC-APRV, PC-MMVI VC-CMV, VC-ACV & VC-
SIMV.
• CRIUSV6
Features;
• Fully Electric Controls
• Blower Drive Ventilatio Type
• Suaable far Adult, Pediatrie & Neonate patient ypes
• Adjustable far pa ient height
Ve n t i lat i on Modes;
• Spn-CPAR PC-CMV, PC-ACV, PC-SIMV, PC-Dual
PAP, PC-AMV, PC APRV, PC-MMV, VC-CMV, VC-
ACV & VC-SIMV
• Manual breatt1, 02 Therapy, Screen lock inspiratory
hold, expiratory hold, sigh, ATC, PCVRJ PPS,
Calibrate, Nebulizer & 02 SuctionVentilatori
• CRIUSV6 • Real time waveforms: Paw, Flow, Volume, ETCO2, SPO2
• OptianaL CO2 & SPO2 (related parameters)
• Loops: P-V: V-F1ow, F1ow-P
• Trends: 1s, 5s, 1 min, 1Omini 30m1n & 60min
• Tidal Volume: 1O -2000ml
• PEEP/CPAP O - 30cmH20
• Oxygen: 21 - 100%
• 'l: E Ratio: 1:1O to 4:1
• :In spi ratory Time (T1): 0.2 - 5 secs
• Flow Trigger: 0.2 to 15I/mìn
• Pressure Trigger: -0.5 - -20cmH2O
• Pressure Control: 5 to 90cmH20, added to PEEP/CPAP
• Pressure Support O to 90crnH20, added to PEEP/CPAP
• Pressure Ramp: O to 2sVentilatori
Technical Specification
• VG70
VCV(A/C) PCV(A/C) PRVC SIMV(VCV)+PSV
SIMV(PCV)+PSV SIMV(PRVC)+PSV SPONT/CPAP+PSV
BIVENT+PSV NIV/CPAP NIV-T NIV-S/T
20~2000 ml
1~80 bpm
0.2~9 s
0~2 s
0~4 s
1:10~4:1
21%~100%
Pressure (-20~0 cmH 2O, above PEEP)
Flow (0.5~20 LPM)
0~35 cmH 2O
0~70 cmH 2O
5~70 cmH 2O
Apnea Ventilation Smart Suction Manual Breath
Insp/ Exp Hold ETCO 2 Measurement
Nebulization Waveform Freeze
Ppeak, Pplat, Pmean, Pmin, PEEP
Vti, Vte, MV, MVspont
ftotal,fspont, I:E
Pressure-Time, Flow-Time, Volume-Time waveforms
Pressure-Volume, Volume-Flow, Flow-Pressure loops
FiO 2, ETCO 2
Compliance(C)
Resistance(R)
• Disponibile in stock
MVleak
RSBI
WOB
PEEPi
Paw high / low MVe high / low Circuit disconnnect
FiO 2 high / low Inspiration / Expiratory tidal volume low
High Respiration Rate Apnea AC Failure Nebulizer OnVentilatori
Technical Specification
Ventilation Modes Volume-Time waveforms
• VG70
VCV(A/C) PCV(A/C) PRVC SIMV(VCV)+PSV Pressure-Volume, Volume-Flow, Flow-Pressure
SIMV(PCV)+PSV SIMV(PRVC)+PSV SPONT/ loops
CPAP+PSV • Gas Monitoring: FiO2, ETCO2
BIVENT+PSV NIV/CPAP NIV-T NIV-S/T • Calculated Values: Compliance(C)
Resistance(R)
Parameters MVleak
• Tidal Volume: 20~2000 ml RSBI
• Respiration Rate: 1~80 bpm WOB
• Tinsp: 0.2~9 s PEEPi
• Tslope: 0~2 s
• Tpause: 0~4 s Alarm
• I:E Ratio: 1:10~4:1 Paw high / low MVe high / low Circuit disconnnect
• FiO2: 21%~100% FiO2 high / low Inspiration / Expiratory tidal
• Trigger Sensitivity: Pressure (-20~0 cmH2O, volume low
above PEEP) High Respiration Rate Apnea AC Failure Nebulizer
Flow (0.5~20 LPM) On
• PEEP: 0~35 cmH2O Low Battery Air /O2 supply down High / Low PEEP
• Psupport: 0~70 cmH2O Leakage out of range Occlusion
• Pinsp: 5~70 cmH2Oì
Technical Data
Special Procedures • Screen: 12〞TFT color touch screen
Apnea Ventilation Smart Suction Manual Breath (detachable)
Insp/ Exp Hold ETCO2 Measurement • Supply Gas: O2, 0.28~0.6 MPa
Nebulization Waveform Freeze • Power Supply: AC100~240 V, 50 Hz/60 Hz
• Communication Interface: RS-232 Port, Nurse
Monitoring call Port, Ethernet Port
• Pressure Value: Ppeak, Pplat, Pmean, Pmin, • Dimension (WxDxH): 322 mm x 375 mm x 366
PEEP mm (Main Unit)
• Volume / Flow Value: Vti, Vte, MV, MVspont 547 mm x 675 mm x 950 mm (Cart)
• Time Value: ftotal,fspont, I:E • Weight: 12.5 kg (Main Unit)
• Real Time Curves: Pressure-Time, Flow-Time, 25 kg (Cart)Ventilatori 360° Visible
Alarm Lamp
• VG70
360° Visible
Alarm Lamp
Superior Mobile ICU ventilator 12”TFT Detachable
Touch Screen
12”TFT Detachable
Touch Screen
• Comprehensive ICU ventilator including BIVENT and PRVC
• Compact, big capacity battery, no air compressor, intra-hospital
mobility
• Flexible device configuration: equipped on a trolley, bed or
Ultra Quiet
ceiling pendant Ultra Quiet
Turbine Inside Turbine Inside
Cost Effective Solution
• Unique metal-based, autoclavable, heated exhalation valve
• Built-in flow sensor, non-consumable design Integrated Power
Supply Solution Integrated Power
Supply Solution
• Upgradeable ventilation system software, with an available
USB port
Built-in Battery,
With Extended
Backup Option
Built-in Battery,
With Extended
Backup OptionAn Optimal Combination of Invasive and Noninvasive Ventilator
e
As noninvasive ventilation is used increasingly in a wide range of clinical situations, we offer a dual solution
VG70 combines the advantages of a flexible noninvasive ventilator with a full-featured invasive ventilator for
Ventilatori
e USB port the ICU
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An Optimal Combination of Invasive and Noninvasive Ventilator Multi-parameter
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As noninvasive ventilation is used increasingly in aCompensation Breathing
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we offer a dual solution
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VG70 combines the advantages of a flexible noninvasive ventilator with a full-featured invasive ventilator for
• VG70
the ICU The Unique Leak Compensation System - Keep precise control on the tidal volume of each breath
delivered to the patient by adjusting compensation dosage automatically
Advanced Trigger Technique - Enhance sensitivity, avoid spurious triggering
An Optimal Combination of Invasive and Noninvasive Ventilator Safe Ventilation Through Whole Treatment Phase
As noninvasive ventilation is used increasingly in a wide range of clinical situations, we offer a dual solution
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Page 2 – Navin Nauth-Misir, Primerdesign Ltd
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of your product, described in the scope Section
of this letter (Section II), subject to the terms of this authorization.
March 20, 2020
I. Criteria for Issuance of Authorization
Navin Nauth-Misir, I have concluded that the emergency use of your product meets the criteria for issuance of an
Group RA QA Director authorization under Section 564(c) of the Act, because I have concluded that:
Primerdesign Ltd.
Unit 1, Watchmoor Point, Watchmoor Road, 1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
Camberley, GU15 3AD, UK including severe respiratory illness, to humans infected by this virus;
Device: Primerdesign Ltd COVID-19 genesig Real-Time PCR assay. 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
Company: Primerdesign Ltd. that your product may be effective in diagnosing COVID-19, and that the known and
potential benefits of your product when used for diagnosing COVID-19, outweigh the
Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in known and potential risks of your product; and
oropharyngeal swab specimens from patients suspected of COVID-
19 by their healthcare provider. Emergency use of this test is 3. There is no adequate, approved, and available alternative to the emergency use of your
limited to authorized laboratories. Page 3 – Navin Nauth-Misir, Primerdesign Ltd Page 4 – Navin Nauth-Misir, Primerdesign Ltd
product. 5
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high II. Scope of Authorization are processed in the same way as the patient samples and are to be run as outlined in the
complexity tests. Instructions for Use for your product: FDA has reviewed the scientific information available to FDA, including the information
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is supporting the conclusions described in Section I above, and concludes that your product (as
Dear Mr. Nauth-Misir: limited to the indication above. described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in
Genesig Easy RNA Internal extraction control (IEC) - added prior to nucleic acid
1 extraction to measure RNA extraction purity, detect PCR inhibition and confirm the Section 564(c) of the Act concerning safety and potential effectiveness.
This letter is in response to your request that the Food and Drug Administration (FDA) issue Authorized Product Details integrity of the PCR run.
an Emergency Use Authorization (EUA) for emergency use of your product, 2 pursuant to
Genesig COVID-19 Positive control template - contains synthetic DNA representing The emergency use of your product under this EUA must be consistent with, and may not
Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). Your product is for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal the SARS-CoV-2 genomic region of interest. The positive control is used to monitor exceed, the terms of this letter, including the Scope of Authorization (Section II) and the
swab specimens from patients suspected of COVID-19 by their healthcare provider. The SARS- for failures of primer/probe reagents and reaction conditions. Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the CoV-2 is generally detectable in oropharyngeal swab specimens during the acute phase of
Negative Extraction Control (NEC) – RNase/DNase free water, run each time RNA is circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C)
Department of Health and Human Services (HHS) determined that there is a public health infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical
extracted from a clinical specimen or sample. described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1),
emergency that has a significant potential to affect national security or the health and security of correlation with patient history and other diagnostic information is necessary to determine patient
No Template (Negative) Control - DNase/RNase free water used to monitor non- your product is authorized for the indication above.
United States citizens living abroad, and that involves the virus that causes COVID-19. 3 infection status. Positive results do not rule out bacterial infection or co-infection with other
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of viruses. specific amplification, cross-contamination during experimental setup, and nucleic
acid contamination of reagents. This EUA will cease to be effective when the HHS declaration that circumstances exist to justify
HHS then declared that circumstances exist justifying the authorization of emergency use of in
To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from the EUA is terminated under Section 564(b)(2) of the Act or when the EUA is revoked under
vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the
oropharyngeal swabs. The purified nucleic acid is then reverse transcribed into cDNA followed Your product also requires the use of additional authorized materials and authorized ancillary Section 564(g) of the Act.
terms of any authorization issued under Section 564(a) of the Act. 4
by PCR amplification and detection with an authorized RT-PCR Master Mix on authorized Real- reagents that are not included with your product and are described in the Instructions for Use.
Time PCR instrument(s). The Primerdesign Ltd COVID-19 genesig Real-Time PCR assay III. Waiver of Certain Requirements
1
For ease of reference, this letter will use the term “you” and related terms to refer to the Primerdesign Ltd.
2
For ease of reference, this letter will use the term “your product” to refer to the Primerdesign Ltd COVID-19 includes the following materials or other authorized materials: oasig OneStep 2X RT-qPCR The above described product, when labeled consistently with the labeling authorized by FDA,
genesig Real-Time PCR assay used for the indication identified above. Master Mix, COVID-19 Primers & Probe Mix, Oasig resuspension buffer, Template preparation entitled “Primerdesign Ltd COVID-19 genesig Real-Time PCR assay Instructions for Use” I am waiving the following requirements for your product during the duration of this EUA:
3
On February 11, 2020, the virus tentatively named 2019-nCoV was formally designated as Severe acute respiratory buffer, Water RNase/DNase free, Genesig COVID-19 Positive control template and Genesig (available at https://www.fda.gov/medical-devices/emergency-situations-medical-
syndrome coronavirus 2 (SARS-CoV-2). Also on February 11, 2020, the disease caused by SARS-CoV-2 was Easy RNA Internal extraction control (IEC). devices/emergency-use-authorizations), which may be revised in consultation with, and with Current good manufacturing practice requirements, including the quality system
formally designated as Coronavirus Disease 2019 (COVID-19). This document uses the updated names. requirements under 21 CFR Part 820 with respect to the design, manufacture,
4
U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration concurrence of, the Division of Microbiology Devices (DMD)/Office of Health Technology 7
Your product requires the following control materials, or other authorized control materials, that Office of In Vitro Diagnostics and Radiological Health (OHT7-OIR)/Office of Product packaging, labeling, storage, and distribution of your product.
that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020. Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health (CDRH), is
5
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act. authorized to be distributed to and used by authorized laboratories under this EUA, despite the IV. Conditions of Authorization
fact that it does not meet certain requirements otherwise required by applicable federal law.
Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
Your product is authorized to be accompanied by the following product-specific information authorization:
pertaining to the emergency use, which is required to be made available to healthcare providers
and patients: Primerdesign Ltd (You) and Authorized Distributor(s) 6
Fact Sheet for Healthcare Providers: Primerdesign Ltd COVID-19 genesig Real- A. Your product must comply with the following labeling requirements under FDA
Time PCR assay regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions
Fact Sheet for Patients: Primerdesign Ltd COVID-19 genesig Real-Time PCR for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)); any appropriate
assay limitations on the use of the device including information required under 21 CFR
809.10(a)(4); and any available information regarding performance of the device,
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that including requirements under 21 CFR 809.10(b)(12).
the known and potential benefits of your authorized product, when used for the qualitative
detection of SARS-CoV-2 and used consistently with the Scope of Authorization of this letter B. You and authorized distributor(s) will make your product available with the authorized
(Section II), outweigh the known and potential risks of your product. labeling to authorized laboratories. You may request changes to the authorized
labeling. Such requests will be made in consultation with, and require concurrence of,
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific DMD/OHT7-OIR/OPEQ/CDRH.
evidence available to FDA, that it is reasonable to believe that your product may be effective for
the indication above, when used consistently with the Scope of Authorization of this letter
(Section II), pursuant to Section 564(c)(2)(A) of the Act. 6
“Authorized Distributor(s)” are identified by you, Primerdesign Ltd, in your EUA submission as an entity allowed
to distribute your device.Ventilatori • VG70
Page 5 – Navin Nauth-Misir, Primerdesign Ltd Page 6 – Navin Nauth-Misir, Primerdesign Ltd
C. You and authorized distributor(s) will provide to authorized laboratories the Fact Sheet M. You may request the addition of other extraction methods for use with your product.
for Healthcare Providers and the authorized Fact Sheet for Patients. You may request Such requests will be made in consultation with, and require concurrence of,
changes to the authorized Fact Sheets. Such requests will be made in consultation DMD/OHT7-OIR/OPEQ/CDRH.
with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
N. You may request the addition of other specimen types for use with your product. Such
D. You and authorized distributor(s) will make available on your website(s) the Fact requests will be made in consultation with, and require concurrence of, DMD/OHT7-
Sheet for Healthcare Providers and the Fact Sheet for Patients. OIR/OPEQ/CDRH.
E. You and authorized distributor(s) will inform authorized laboratories and relevant O. You may request the addition and/or substitution of primers or probes for use with your
public health authorities of this EUA, including the terms and conditions herein, and product. Such requests will be made in consultation with, and require concurrence of,
any updates made to your product, authorized labeling and authorized Fact Sheets. DMD/OHT7-OIR/OPEQ/CDRH.
F. Through a process of inventory control, you and authorized distributor(s) will maintain P. You may request the addition and/or substitution of control materials for use with your
records of the authorized laboratories to which they distribute the test and number of tests product. Such requests will be made in consultation with, and require concurrence of,
they distribute. DMD/OHT7-OIR/OPEQ/CDRH.
G. You and authorized distributor(s) will collect information on the performance of your Q. You may request the addition and/or substitution of other ancillary reagents and
product. You will report to FDA any suspected occurrence of false positive and false materials for use with your product. Such requests will be made in consultation with,
negative results and significant deviations from the established performance and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH. Page 7 – Navin Nauth-Misir, Primerdesign Ltd Page 8 – Navin Nauth-Misir, Primerdesign Ltd
characteristics of the product of which you become aware.
R. You will evaluate the analytical limit of detection and assess traceability 7 of your
H. You and authorized distributor(s) are authorized to make available additional product with any FDA-recommended reference material(s). After submission to FDA Instructions for Use. Deviations from the authorized procedures, including the This test is only authorized for the duration of the declaration that circumstances
information relating to the emergency use of your product that is consistent with, and and DMD/OHT7-OIR/CDRH’s review of and concurrence with the data, You will authorized instruments, authorized extraction methods, authorized clinical specimen exist justifying the authorization of emergency use of in vitro diagnostic tests for
does not exceed, the terms of this letter of authorization. update its labeling to reflect the additional testing. Such labeling updates will be made types, authorized control materials, authorized other ancillary reagents and authorized detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21
in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH. materials required to use your product are not permitted. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked
Primerdesign Ltd (You) sooner.
W. Authorized laboratories that receive your product will notify the relevant public health
S. You will complete the agreed upon bridging study to add at least one addition authorities of their intent to run your product prior to initiating testing.
I. You will notify FDA of any authorized distributor(s) of your product, including the extraction method(s) to your product within 15 days of the date of this letter. After No advertising or promotional descriptive printed matter relating to the use of your product
name, address, and phone number of any authorized distributor(s). submission to FDA and DMD/OHT7-OIR/CDRH’s review of and concurrence with the may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.
X. Authorized laboratories using your product will have a process in place for reporting test
data, you will update its labeling to reflect the additional extraction method(s). Such results to healthcare providers and relevant public health authorities, as appropriate.
J. You will provide its authorized distributor(s) with a copy of this EUA and communicate labeling updates will be made in consultation with, and require concurrence of, The emergency use of your product as described in this letter of authorization must comply
to authorized distributor(s) any subsequent amendments that might be made to this EUA DMD/OHT7- OIR/OPEQ/CDRH. with the conditions and all other terms of this authorization.
Y. Authorized laboratories will collect information on the performance of your product and
and its authorized accompanying materials (e.g., Fact Sheets). report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-
T. You will track adverse events, including any occurrence of false results and report to Reporting@fda.hhs.gov) and You (support@primerdesign.co.uk) any suspected
K. You may request changes to the Scope of Authorization (Section II in this letter) of your V. Duration of Authorization
FDA under 21 CFR Part 803. occurrence of false positive or false negative results and significant deviations from the
product. Such requests will be made in consultation with DMD/OHT7- established performance characteristics of your product of which they become aware.
OIR/OPEQ/CDRH, and require concurrence of, Office of Counterterrorism and This EUA will be effective until the declaration that circumstances exist justifying the
Authorized Laboratories
Emerging Threats (OCET)/Office of the Chief Scientist (OCS)/Office of the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of
Z. All laboratory personnel using your product must be appropriately trained in RT-PCR COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under
Commissioner (OC) and DMD/OHT7-OIR/OPEQ/CDRH. U. Authorized laboratories using your product will include with result reports of your techniques and use appropriate laboratory and personal protective equipment when Section 564(g) of the Act.
product, all authorized Fact Sheets. Under exigent circumstances, other appropriate handling this kit, and use your product in accordance with the authorized labeling.
L. You may request the addition of other instruments and associated software for use with methods for disseminating these Fact Sheets may be used, which may include mass
your product. Such requests will be made in consultation with, and require concurrence media. Primerdesign Ltd (You), Authorized Distributors and Authorized Laboratories
of, DMD/OHT7-OIR/OPEQ/CDRH.
V. Authorized laboratories using your product will use your product as outlined in the AA. You, authorized distributors, and authorized laboratories using your product will
ensure that any records associated with this EUA are maintained until otherwise notified Sincerely,
7
Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material. by FDA. Such records will be made available to FDA for inspection upon request.
Conditions Related to Advertising and Promotion
____________________________
BB. All advertising and promotional descriptive printed matter relating to the use of RADM Denise M. Hinton
your product shall be consistent with the Fact Sheets and authorized labeling, as well as Chief Scientist
the terms set forth in this EUA and the applicable requirements set forth in the Act and Food and Drug Administration
FDA regulations.
CC. All advertising and promotional descriptive printed matter relating to the use of Enclosures
your product shall clearly and conspicuously state that:
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized
laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-
CoV-2, not for any other viruses or pathogens; andVentilatori • VG70
Novacyt S.A. The Novacyt Group is an international diagnostics business generating an increasing
portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics
("Novacyt" or the "Company") product development, commercialisation, contract design and manufacturing. The
Company's lead business units comprise of Primerdesign and Lab21 Products,
supplying an extensive range of high-quality assays and reagents worldwide. The
COVID-19 test eligible for WHO Emergency Use Group directly serves microbiology, haematology and serology markets as do its global
partners, which include major corporates.
Listing
For more information please refer to the website: www.novacyt.com
Paris, France and Camberley, UK – 8 April 2020 – Novacyt (EURONEXT GROWTH: ALNOV;
AIM: NCYT), an international specialist in clinical diagnostics, announces that its test for COVID- About COVID-19
19 (Z-Path COVID-19-CE IVD) has been listed as eligible for World Health Organization (WHO) Researchers at the Chinese Centre for Disease Control and Prevention and their
procurement under the WHO Emergency Use Listing (EUL) process. The test will be eligible for collaborators have sequenced the 2019 novel coronavirus (COVID-19) pathogen from
procurement for one year, unless circumstances dictate otherwise. The test has been developed patient samples and have found it to be genetically distinct from the severe acute
by Novacyt’s molecular diagnostics division, Primerdesign, based in Southampton, UK. respiratory syndrome (SARS) virus that caused an epidemic in 2002 and 2003, as well
as from the Middle East respiratory syndrome (MERS) virus that was detected in 2012.
The EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics
and in vitro diagnostics with the ultimate aim of expediting the availability of these products to
people affected by a public health emergency. It will assist interested UN procurement agencies
and Member States in determining the acceptability of using specific products, based on an
essential set of available quality, safety, and efficacy and performance data. The procedure is a
key tool for companies wishing to submit their products for use during health emergencies.
Graham Mullis, Chief Executive Officer of Novacyt, commented:
“
”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU)
596/2014.
- End –
Contacts
Novacyt SA
Graham Mullis, Chief Executive Officer
Anthony Dyer, Chief Financial Officer
+44 (0)1276 600081
SP Angel Corporate Finance LLP (Nominated Adviser and Broker)
Matthew Johnson / Charlie Bouverat (Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
+44 (0)20 3470 0470
FTI Consulting (International)
Victoria Foster Mitchell / Mary Whittow
+44 (0)20 3727 1000
victoria.fostermitchell@fticonsulting.com / mary.whittow@fticonsulting.com
FTI Consulting (France)
Arnaud de Cheffontaines
+33 (0)147 03 69 47
arnaud.decheffontaines@fticonsulting.com
About Novacyt Group
Page 1 of 2 Page 2 of 2Antipandemic System CABINE DI DISINFEZIONE
Mobile aerosol
disinfection
version
A01
The thermometry and disinfection integrated channel from
Nokonden is used for disinfection of body, pet, goods and other
objects in public space entrance when emergency public health
events occur. The operation of the equipment is under intelligent
control, and there is no need for special personnel to operate.
The equipment has many functions, such as automatic liquid
feeding, real-time display of running state, automatic reaction of
entry and exit objects, fog, quantity and spray time can be
Comes with adjusted; equipped with casters and handles, convenient for
induction, mobile and rapid deployment; exquisite appearance, scientific and
wash hands to safe in design, and convenient in recycling waste liquid, and
disinfect protect the environmentAdvantages 1. Atomization disinfection function, comprehensive disinfection to ensure safety 2. Non-contact alcohol sterilizer specially for hand using to avoid crossing infection 3. Sole disinfection 4. Stable control disinfectant quantity to ensure disinfection effect 5. Reminder of equipment status 6. Automatic fluid infusion & Waste liquid collection 7. Illumination of the channel with 24 hours using 8. Universal casters with brakes, Movable 9. Original patent & Attractive appearance Patent Application No. 202030053956.4 202020183189.3
10-40°C
Working (Unusable below 0 degrees, Spray
Type A01 1-3Kg/H
environment disinfectant freezes efficiency
and cannot be atomazied)
Spray area
Inner
Size L180*W110*H241cm L180*W100*H197cm protection Magnetic PVC curtain
channel size
method
5-15 seconds
Spray recommended
Working Disinfection Automatic induction
AC220V
spray
disinfection (Stay according to personal needs,
Voltage type the device does not make
waiting time mandatory control)
100-400PPM diluted
Rated The length of Disinfectant solution of chlorine dioxide,
900 W 116cm
power spray channel type 200PPM diluted solution
of hypochlorous acid
Equipment Cold rolled Fog making Ultrasonic Disinfection 15L
material steel plate way atomizing tank capacity
Microwave induction start, Hand
Equipment housing Independent area
Rainproof Spray control delay stop
with rain protection disinfection induction spray type,
function (Open access doors are not rainproof) method (Delay adjustable: 5.60 seconds)
disposable disinfectant
2 fog outlets typeShandong Nokonden Anti epidemic Equipment Co., Ltd. Nokonden is a wholly-owned subsidiary of Shandong JEKEEN Intelligent Manufacturing Technology Co., Ltd., focusing on the research and development and manufacturing of anti epidemic equipment such as temperature measurement, disinfection, and mobile medical space. The company has an intelligence factory of 60,000 m² and a R&F team of 100 people. Relying on its strong R&D and manufacturing capabilities, it has developed dozens of products such us temperature measurement channels, disinfection channels, and medical cabins. It provides safe, accurate and flexible ant- epidemic equipment solutions for all kinds of public places, such as schools, hospitals, communities, enterprises and institutions, public transportation, and leisure places, etc.
Antipandemic System Sistemi di tracciamento temperatura corporea
Sistemi certificati di misurazione istantanea della temperatura corporea ACCURATEZZA DELLA MISURAZIONE ± 0.3°C
Sistemi certificati di misurazione istantanea della temperatura corporea ACCURATEZZA DELLA MISURAZIONE ± 0.3°C
Termocamere
KIT BASE
JQ-D70Z TPC-BF3221-TB7F8
Meglio conosciuto come «Blackbody» è uno strumento certificato che, inserito Telecamera ibrida con misurazione della temperatura che fornisce
nel campo di ripresa, fornisce un riferimento di temperatura costante e preciso simultaneamente un’immagine normale e una termica della scena ripresa. Un
che la telecamera sfrutta per auto calibrarsi e aumentare l’accuratezza della algoritmo di intelligenza artificiale riconosce le figure umane e permette di
misurazione. misurare la temperatura del volto, escludendo qualsiasi altra fonte di calore che
possa costituire un falso allarme, alla distanza ottimale di 3 metri.Termocamere
PRODOTTI OPZIONALI
CENTER330 NVR5X-I IVSS7X
Server & Workstation Registra il video e aggiunge la possibilità di Registra il video e aggiunge la possibilità di
compatta con Win10Pro x64. generare un evento se una delle persone generare un evento se una delle persone
inquadrate ha il volto coperto, per esempio da inquadrate ha il voltocoperto, per esempio, da
una mascherina, fino a 4 canali. una mascherina, fino a 8 canali.Termocamere
ACCESSORI
SWP1220 RAW021-00 VTC-990
Alimentatore 12 VDC/2A per Adattatore cavalletto/telecamera, Cavalletto tripod per telecamera/
telecamera cavalletto/blackbody blackbodyTERMOCAMERE
Sistema di misurazione Tramite l’interfaccia web della telecamera è possibile visualizzare in tempo reale la temperatura rilevata e
agire di conseguenza, avviando, per esempio, la comunicazione bidirezionale verso il microfono e lo speaker
base integrati nella telecamera al fine di separare il soggetto dalla folla. Al superamento della soglia di temperatura
è possibile attivare il led bianco intermittente e/o riprodurre un messaggio audio dallo speaker.
0#%$1)2+3
!"#"$%&"'%
()'*+%
,")-.%/"TERMOCAMERE
Sistema di misurazione
multi-punto
1)+*'.%02
!"#$%&'
I vari punti di rilevazione vengono (")"*+,"&+
centralizzati sulla workstation tramite -.&/0+
il software DSS Express. I vantaggi
rispetto alla soluzione base sono:
• Centralizzazione di più punti di ì
misurazione, in rete locale o da remoto
• Mappa grafica
• Ricezione evento con messaggio di 1)+*'.%02
notifica, allarme sonoro e finestra pop-
up del canale interessato
(")"*+,"&+
• Possibilità di linkare l’evento di un -.&/0+
canale a un altro (es.: la rilevazione di 3%&'4#+#/%5
temperatura anomala di un canale può
essere linkata alla chiusura dell’uscita di
allarme di un altro dispositivo)TERMOCAMERE
Sistema di misurazione 4.'/$2"35
multi-punto con -+.+/'0+#'
12#(3'
archiviazione e
metadati *+&,"#$
4.'/$2"35
-+.+/'0+#'
12#(3'
I vari punti di rilevazione vengono
centralizzati sulla workstation tramite
il software DSS Express. I vantaggi
rispetto alla soluzione precedente
sono: 4.'/$2"35
*678"81699
• Rilevamento di volti coperti (fino a 4 -+.+/'0+#'
canali con NVR5-I, fino a 8 canali con 12#(3'
IVSS-1I)
!"#$%&'&(")
• Archiviazione delle immaginiTPC-BF3221-T
· Thermal Network Value Hybrid Bullet Camera
·
· 256x192 VOx uncooled thermal sensor technology
•
• Athermalized Lens (thermal camera), Focus-free
· 1/2.8” 2Megapixel progressive scan Sony cmos
•
· Support ROI, Motion Detection, Color Palettes
•
• Support measure body temperature,
· Measurement Accuracy: Max (±0.3°C, with black-body)
•
· Active deterrence with white light & siren
•
• Built-in 2/2 alarm in/out
· Built-in
• Micro SD memory, IP67, PoE
·
Functions
Uncooled Vox Technology
Dahua thermal cameras use uncooled Vox sensor technology . Because of small size and better performance,
it’s cost-effective solution for thermal security.
System Overview High Sensitivity
High thermal sensitivity(BLC Mode
TPC-BF3221-T
White Balance
Lens Type
Focus Control
Lite Series| TPC-BF3221-T Focal Length Region of Interest
Technical Specification Lite Series| TPC-BF3221-T
Angle of View
Compression Flip
Image Sensor Image Sensor
MirrorCompression
/
Image Sensor
Frame Rate /
Frame Rate
Compression
Spectral Range Bit Rate Control
Image Setting Bit Rate Spectral Range Bit Rate Control
Image Setting Ethernet
Bit Rate
1
BLC Mode
White Balance BLC Mode
Focal Length
Lens Type Interoperability
White Balance
Max Aperture
Focus Control Angle Lens Type
of View Streaming Method
Focal Length Focus Control
Region of Interest Max. User Access
Focal Length Region of Interest
Angle of View Measurement Range
Edge Storage
Angle of View
Measurement Accuracy
Flip
Web Viewer
Image Sensor Measurement Mode
Mirror Flip
Management Software
Image Sensor
Mirror
Measurement Rule
CompressionRegion of Interest
TPC-BF3221-T
Flip
Technical
Mirror
Specification Lite Series | TPC-BF3221-T
Lite Series | TPC-BF3221-T
Compression Type
Type
PC-BF3221-T
Video Interface
Ethernet PC-BF3221-T
Video
Audio Interface
Interface
Audio Interface
RS485
291.0[11.46"]
103.8[4.09"]
192.5[7.58"]
Alarm
RS485
291.0[11.46"]
Interoperability 103.8[4.09"]
192.5[7.58"]
Alarm
97.2[3.83"]
Streaming Method
97.2[3.83"]
Max. User Access
Edge Storage
Operating Condition
Web Viewer
Operating Condition
Strorage Conditions
Management Software
Strorage Conditions
Casing
Casing
Weight ＜
Weight ＜Grazie www.013industries.com
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