Product Description

2020

Multiplex Real Time PCR Kit for Novel Coronavirus

2019-nCoV(ORF1ab)/Influenza A/Influenza B

Uni-medica：

Years of experience in molecular diagnosis of pathogens

Shenzhen Uni-medica Technology Co., Ltd (Uni-medica) is a national high-tech

enterprise. It has established cooperation and jointly performed a number of scientific

research projects with the Hong Kong University of Science and Technology,

Shenzhen University and Chinese Academy of Sciences. Uni-medica was also selected

as one of the top 100 new Chinese innovative enterprises.

The company takes the technical innovation of molecular detection methods as the core driving force, and focuses

on the R&D and industrialization of molecular diagnostic products aiming at prevention and control of infectious

diseases and genetic diseases. Uni-medica provides total solution of accurate diagnosis of infectious diseases and

genetic diseases based on multi-omics technologies, including multiplex PCR, NGS technology and flow cytometry. Uni-

medica is qualified by ISO 13485 and CFDA quality control system. The pathogen molecular detection products are daily

used in hundreds of hospitals, Centers for Disease Control and Prevention and Quarantine Laboratories throughout the

country, providing strong support for prevention and control of infectious diseases.

1R & D ideas

R & D ideas

At present, the epidemic situation has been controlled

to a certain extent, and it is very important to make

differential diagnosis with other respiratory tract

infections.

• The novel coronavirus 2019-nCoV is required to be

differentiated from common respiratory pathogens

according to the ‘Novel Coronavirus 2019-nCoV diagnosis

and treatment plan’ issued by the National Health

Commission. Uni-medica developed the kit, Multiplex Real

Time PCR Kit for Novel Coronavirus 2019-nCoV

(ORF1ab)/Influenza A /Influenza B.

The Influenza A and the Influenza B pathogens had

been verified by more than ten thousand samples,

and had been widely used in more than 100 hospitals

and Centers for Disease Control and Prevention.

R & Dideas

2Product Description

Product Description

and

Kit Contents

Components 50 tests/kit

RT-PCR reaction buffer 925μL × 1 tube

RT-PCR enzyme mix 75μL × 1 tube

Positive control 100μL × 1 tube

Negative control 100μL × 1 tube

Product Appearance

Key Features

Compatible with multiplebrands of Real-Time PCRsystems;

CV ≤ 5%;

4. High Precision:

Limit of detection is 200 copies/mL;

1. High Sensitivity:

No cross reaction with SARS-CoV, MERS-CoV, CoV-HKU1, CoV-

OC43, CoV-229E, CoV-NL63, Parainfluenza Virus, Human

Adenovirus, Human Rhinovirus, Respiratory Syncytial Virus (A),

Respiratory Syncytial Virus (B), Enterovirus A, Staphylococcus

Aureus, Streptococcus Pneumonia, Klebsiella Pneumonia.

3. High Specificity

2. High Flexibility:

~1.5 hours

6. Rapid Reaction Time:

the whole process monitored by internal control.

5. Internal Control

Results

• Primer sets and FAM labeled probe are designed for specific detection ofORFlab gene of 2019-nCoV, VIC labeled probe for internal control, ROX labeledprobe for Influenza A, CY5 labeled probe for Influenza B.

Parameter

【Applicable Instruments】

Real-Time PCR System: ABI 7300/7500/7900, ViiATM 7, QuantStudio 7 flex, Roche

Lightcycler 480, Agilent Mx3000P/3005P, Rotor-GeneTM 6000/Q, Bio-Rad CFX96

TouchTM/iQTM 5，SLAN-96S，MA6000

PS：Color Compensation should be set when the instrument is lightcycle 480

【Storage and Expiration】

This kit expires in 12 months when stored at -20±5℃ and in prevention of light.

Real-Time PCR Amplification

Uni-medica provides a high-throughput and rapid solution for screening and detecting

respiratory pathogens. It includes the Disposable Virus Sampling Tube, Automatic

Nucleic Acid Extraction System, Nucleic Acid Extraction Reagent, Real Time PCR Kit for

Novel Coronavirus 2019-nCoV and Real Time PCR Kit for Respiratory Pathogens.

Automatic Nucleic Acid Extraction & Detection Solution

Certification

MHRA

10 South Colonnade

Canary Wharf

London

E14 4PU

United Kingdom

Dear Dr Wang

IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATIONS 2002: REGULATION 44

Registration of manufacturers of In-Vitro Diagnostic Medical Devices and devices for Performance Evaluation

Thank you for informing the Competent Authority of the details of Manufacturers Name:- Shenzhen Uni-medica Technology Co., Ltd. located at Manufacturers Address:- Room 202, Block 6th, LiuXian Culture Park, XiLi Town, NanShan District, Shenzhen, Guangdong, China 518055 for whom you are acting as the authorised representative and for supplying the medical device information.

Your registration has been recorded based on your declaration that you have determined that the device(s) fall within the definition of “in vitro diagnostic medical device”, and that you have classified it/them correctly considering the intended purpose(s) and mode(s) of action. In accepting your registration, I should make clear that the Competent Authority does not examine each individual notification and therefore cannot and does not necessarily endorse these determinations.

Please note this letter does not represent any form of accreditation, certifcation or approval by the UK Competent Authority.

If you stop placing devices on the market or if you are not complying with the Regulations you should inform us as required by the Regulations. You should be aware that it is an offence to place on the market CE marked devices that do not comply with the Regulations.

The information you provided has been recorded against the reference number shown at the top of this letter, which we ask you to quote in all future correspondence and communications.

Please inform us of any of the following changes;

• the company information

• additional generic groups of devices or, for Annex II or Self-Test devices, additional devices

• discontinuation of a generic group of devices or, for Annex II or Self-Test devices, discontinuation of devices

You should submit your change of registration via DORS with the required statutory fee, which should be accompanied with the information when it is supplied, (the fee is payable for each record notified, and you may place multiple changes on one record).

Thank you for registering the following generic groups of devices

1. Part 5: IVDs which are not Annex II and not self-test devices 2.

Our Ref: IVD001175 Dr Edward Wang Wellkang Ltd 16 Castle Street Dover Kent CT16 1PW United Kingdom 18 May 2020

Order Information

Product Specs ITEM No. Description

Multiplex Real Time PCR Kit for Novel Coronavirus 2019-nCoV(ORF1ab)/Influenza A/Influenza B

50 tests/kit R033ORF1ab gene,Influenza A, Influenza B,Internal control

Disposable Virus Sampling Tube 50 pcs/kit R029 PP fiber swabs and Virussampling tube

Nucleic Acid Extraction Reagent 64T,96T,384T,100T,300T,1000T

R024,R025

Automatic and manualextraction reagent

Automatic Nucleic Acid Extractor（Magnetic Bead Method）

Auto-pure 32Auto-pure 96

/ Extraction time: 11~23 minutes

Real-Time PCR FluorescenceQuantitative PCR System

MA6000 / Flux: 1~96 samplesExtraction time: 1.5 hours

Thanks！