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Yocon virus sampling products were well accepted globally.

Virus Sampling Kit

This non-inactivated virus sampling tube, which is first registered under Class II medical device in China, is suitable for collection and transport of virus samples and isolation of virus strains

Product use

This non-inactivated virus sampling tube, which is first registered under Class II medical devices in China, is suitable for collection and transport of COVID-2019, influenza, HFMD, rubella, measles, norovirus, rotavirus and related samples, and more suitable for common molecular diagnostic items such as nucleic acid detection, gene sequencing, virus isolation and immunoassay.
Product video

Product type

Product name

Item No.

Reagent volume

Product specification

Tube specification

Swab quantity

Non-inactivated

Virus sampling kit

MT0301-1

3.5mL

20 tubes/carton

φ16×100mm

One flocked swab

MT0301-2

3.5mL

20 tubes/carton

φ16×100mm

Two flocked swabs




MT0301 series, registered under Class II medical devices

The viral sampling tube product registered under Class II medical devices is significantly different from the commercially available common product filed under Class I category. YOCON has been rooted in the formulation research, registration and testing of this product for many years.

Difference   between Class II virus sampling tube and Class I virus sampling tube

Category

Class II sampling tube

Class I sampling tube

Product qualification

Approval system

Filing system

Registration and testing required?

Yes (Beijing Institute of Medical Device Test)

No

Clinical trials required?

Yes (qualified based on clinical samples)

No

Qualification time

2   years

1 day

Regulatory authority

Beijing Municipal Medical Products Administration

Haidian District Market Supervision Bureau

A flight inspection required?

Yes

No

Production conditions to be reviewed?

Yes

No

Sterile swabs to be used?

Yes

No

User responsibility

Small (NMPA bears regulatory responsibility)

Big (users are responsible for their own choices)


Product advantages

Product qualification

MT0301 series virus sampling products are registered under Class II medical devices in China

Excellent product performance

The virus sampling kit has a lower Ct value than Hanks solution at any virus concentration, when stored at low-temperature or ambient temperature

Elution beads added to promote sample release

The elution beads are added to the reagent to promote sample release

Higher positive virus isolation rate

The virus can be isolated stably within 48 hours by using the virus sampling kit at 2-8 ℃ or room temperature

Transport stability guaranteed

The tube dies are independently developed through cooperation with structural experts to prevent sample leakage and guarantee transport stability

Safe and residue-free by continuous sterilization by irradiation

The expensive sterilization by irradiation is used to guarantee the safety of operators with sterilization integrity

Product formulation designed to eliminate contamination

With a 15-year history of proven manufacturing processes and Class 10,000 clean production environment, YOCON offers you sampling products with a sterility assurance level of 10e-6

High-quality flocked swabs

YOCON sampling swabs have been structurally studied to ensure the proper arrangement of flock for maximum adsorption and release of samples

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