Disposable Virus Sampling Tube

Type Description Qty.

1×3mL of classic medium in tube 3ml/pcs
VST-01 20pcs/Box,50pcs/Box,
1×3mL classic medium in tube, 1×pp fiber swab 100pcs/Box

1×3mL of inactivated medium in tube 3ml/pcs

VST-02 20pcs/Box,50pcs/Box,
1×3mL inactivated medium in tube, 1×pp fiber swab 100pcs/Box
1×3mL of stroke-physiological saline solution in tube 3ml/pcs
VST-03 20pcs/Box,50pcs/Box,
1×3mL stroke-physiological saline solution in tube,1×pp fiber swab 100pcs/Box
 Disposable Virus Sampling Tube

Disposable Virus Sampling Tube Limitations

INSTRUCTION FOR USE Disposable Virus Sampling Tube is intended to be used with the medium tubes and swabs
Product Name provided in this product. The use of tubes of medium or swabs from any other source could
Disposable Virus Sampling Tube affect the performance of the product.

Product Description Instructions for use

Inactivated Disposable Virus Sampling Tube is based on Hank's balanced salt solution
enriched with inactivator and nucleic acid protective agents. It is used for nucleic acid
extraction of samples such as viruses，mycoplasma，chlamydia and ureaplasma.
Classic Disposable Virus Sampling Tube is an upgrade from the Hank's solution. Additional
various components，such as BSA，HEPES，amino acids，cryoprotectant，etc.，are added
to enhance the virus integrity. It can be used for nucleic acid extraction of virus，mycoplasma，
chlamydia and ureaplasma samples and later virus isolation.
The pH of the preservation solution is 7.4±0.5. The medium contains antibiotics and
Unwrap the package, take out Use the swab to collect
antimycotics for the purpose of inhabitation of bacteria and yeasts overgrowth. It helps to
the swab. samples and put it back into
maintain the cellular integrity and preserve the viruses，mycoplasma，chlamydiae and
the tube
ureaplasma..

Size
VST-01, VST-02, VST-03
3mL×20Pcs, 3mL× 50Pcs, 3mL×100Pcs

Kit Contents
Type Components
Break the swab rod and leave Screw the lid tightly and mark
1×3mL of classic medium in tube
the sampling parts inside the on the tube.
VST-01 1×3mL classic medium in tube, tube.
1×pp fiber swab
1×3mL of inactivated medium in Principles of the Procedure after Specimen Collection
tube When collect specimens with Inactivated Disposable Virus Sampling Tube，tube can be
VST-02
1×3mL inactivated medium in tube, transported to the laboratory at room temperature(5-25℃) within 7 days. It's better with ice
1×pp fiber swab bag. Avoid repeated freeze-thaw cycles. For best performance，complete testing within 24
1×3mL of stroke-physiological hours in controlled temperature environment.
saline solution in tube When collect specimens with Classic Disposable Virus Sampling Tube ， tube can be
VST-03
1×3mL stroke-physiological saline transported to the laboratory at 2-8℃ within 2 days. If it can not be delivered to the
solution in tube,1×pp fiber swab laboratory within 48hours，it should be stored at -70℃ or below，and ensure that the collected
Precautions: Materials required for isolation， extraction and culture of viruses， mycoplasma， specimens are delivered to the laboratory within 1 week. Avoid repeated freeze-thaw cycles.
chlamydiae and ureaplasma. For best performance，complete testing within 24 hours.

Storage and Expiration Precautions

This product expires in 12 months when stored at room temperature and in prevention of light. 1.Please read this instruction carefully before use.
Manufacture date and expiration date are printed on the label. 2.Disposable Virus Sampling Tube should be used by trained and qualified personnel.
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 Disposable Virus Sampling Tube
3.Do not use beyond expiration date. Do not use if the original seal of the medium and swab is
Batch Code Do Not Reuse
damaged. Check the outer packaging of the product before use to make sure it is complete
with no content overflow. The labeling is unbroken with clear content and no shedding. The Expiration Date in
preservation solution should be pre-loaded in the sampling tube. It is normal phenomenon to Year-Month-Day Date of Manufacture
have precipitate at low temperature. Inactivated Disposable Virus Sampling Tube is a clear Format
solution，do not use if the color of the medium turned turbid，or cloudy；Classic Disposable
Virus Sampling Tube is an orange-red color solution， do not use if the color of the medium Consult instructions
Temperature Limitation
has changed from light orange-red. for use
4.Avoid the medium in contact with eyes and skins.
5.Do not contaminate the tip of the swab before taking samples. Keep away from
caution
6.Be careful when the swab is inserted into the mouth for oral sampling. Avoid the risk of sunlight
choking.
7.For single use only. Different patients are prohibited from using the same swab or tube.
8.Specimens for the search of viruses，mycoplasma，chlamydiae and ureaplasmas involves risk
of infection，and must be collected and handed using proper PPE against biological risk
according to published guidelines and local regulations.
9.Sample sites，condition，volume and timing of specimen collected are significant variables in
obtaining reliable culture results. Follow recommended guidelines for specimen collection.
10.The use of this product in combination with diagnostic kits or instruments must be
validated by the user prior to use.
11.Waste must be disposed of in compliance with local legislation. If necessary, take
appropriate precautions for infected material.

Company Information
Shenzhen Uni-medica Technology Co. Ltd
Tel: 86-0755-86505501 Fax: 86-0755-86505501-822
Registered and manufacturing address: Room 202,Block 6th,LiuXian Culture Park, XiLi Town,
NanShan District, Shenzhen, Guangdong Province, P. R. China.
Post code: 518055 Website: www.uni-medica.com

CMC Medical Devices & Drugs S.L.

Address: C/ Horacio Lengo Nº 18, CP 29006, Málaga, Spain

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Manufactured By CE Mark

Authorized
Catalog Number
Representative

In Vitro Diagnostic Potential Biological

Medical Device Hazards After Use

2 / 2
 EC REP CERTIFICATE

CMC MEDICAL DEVICES & DRUGS SL

NO. CMC/CE/2020/02072020.7

CONFIRMED THAT CMC MEDICAL DEVICES & DRUGS S.L. Is the European Authorized
Representative of
Shenzhen Uni-medica Technology Co. Ltd
Room 202,Block 6th,LiuXian Culture Park, XiLi Town, NanShan
District, ShenZhen, Guangdong Province, P.R.China

The certificate remains valid until the expiration agreement of EC REP, manufacturing
conditions, the quality system or relevant legislation are changed. The validity is conditioned
by positive results of periodic surveillance audits.
The product liability rests with the manufacturer in accordance with applicable directive and
standard, after fulfilling of the relevant EU legislation requirements, the manufacturer shall
affix relevant CE marking to all above mentioned models of the medical device.

Complies with the applicable essential requirements of the council directive 98/79/EEC in
vitro diagnostics as amended.

The products in Annex I was registered in Spanish MOH with number RPS/1611/2020

Issued on: 02/07/2020 Valid until: 01/07/2021

Authorized Signatory
CMC Medical Devices & Drugs SL

www.cmcmedicaldevices.com
EC REP CERTIFICATE

ANNEX I Medical Device Products

Disposable Virus Sampling Tube

Nucleic Acid Extraction Reagent

Sample Release Reagent

Real Time PCR Kit for Novel Coronavirus 2019-nCoV (ORF1ab, N)

Real Time PCR Kit for Novel Coronavirus 2019-nCoV

www.cmcmedicaldevices.com
 

 
 
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