新葡萄8883(老版)官网-ios/安卓/手机版

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
Non-inactivated	Virus sampling kit	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

新葡萄8883(老版)官网-ios/安卓/手机版

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Virus Sampling Kit

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