[Product Name] Sample release

[Packaging specification] 0.5 mL / tubing, 1 mL / tubing, 2 mL / tubing, 3 mL / tubing, 4 mL / tubing, 5 mL / tubing, 6 mL / tube, 10 mL / tubing, 40 mL / tubing, 100 mL /

Bottle, 500ml / bottle

[Intended use] for the sample to be tested to release the object in the sample from the state bound to other substances.so as to do

Test the tested using in vitro diagnostic reagents or instruments.

[Main components] It is mainly composed of trihydroxymethylomethane and sodium chloride.

[Storage conditions and shelf life] This product is stored at 5-25℃ for a valid period of 12 months.

[usage method]

1. The swab sample, according to the sampling requirements, break the sampled in vitro swab breaking point, so that the swab sample is completely immersed in the sample containing release

In the collection tube of the agent, tighten the tube cover for inspection as the sample to be tested.

2. Sputum / saliva, extracted substance type sample (nasopharynx / respiratory tract), according to the sampling requirements, the sample collected in the sample release agent

In the header, it is submitted for inspection as samples to be tested.

After sampling, the collection tube is placed at room temperature for 10 minutes, and then shaken and mixed well for 30 seconds. The nucleic acid is released into the sample release agent and can be directly absorbed

The supernatants were subjected to PCR, RT-PCR, LAMP, or RT-LAMP and other amplification reactions.

[matters need attention]

1. The sample shall be sent to the corresponding laboratory within 2 working days after collection, and the storage temperature is 2-8℃. If it cannot be sent to the experiment within 48 hours

In the room, -70℃ or below shall be stored, and the collected specimens shall be sent to the corresponding laboratory within 1 week, and the specimens shall avoid repeated freezing

melt.

2. Users should carry out basic protection, such as wearing medical masks and gloves;

3. If the product exceeds the validity period, the packaging is damaged, and the liquid discoloration, turbidity, leakage and other phenomena are prohibited;

4. It is forbidden to contact the sample release agent directly with the collected personnel.

5. It is forbidden to use sampling liquid to infiltrate swabs before sampling.

6. This product is a disposable product, which is only used for the collection, transportation and preservation of clinical collection of virus specimens, and shall not be used beyond the intended use.

7. The virus samples shall be collected by professionals in strictly following the sampling procedure; When the specimens are tested, the experiment shall meet the safety level

Room operation.

8. The treatment of the discarded sampling equipment and sampling pipe shall be carried out in accordance with it or other relevant regulations.

[manufacturing enterprise]

Company name: Suzhou Chenxi Biotechnology Co., LTD

Address: B-302, B-303, B-304, B-316, B-316-1, No.188, Suhong East Road, Suzhou Industrial Park

Production address: B-316, No.188, Suhong East Road, Suzhou Industrial Park

Website: www.cx-med.com

Contact number: 0512-65209150

Fax: 0512-65209150

[Date of specification approval and modification] 01 / 2021

[Product Technical Requirements No.]Su Su equipment No.20201111

[Medical Device Product Record Certificate No.]
Su Su equipment No.20201111

[Medical Device Production Record Certificate No.] Susu Food and Drug Administration Device Production Preparation 20151002