 |
Product purpose
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 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 | Excellent product performance |
MT0301 series virus sampling products are registered under Class II medical devices in China. | 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 | Higher positive virus isolation rate |
The elution beads are added to the reagent to promote sample release. | The virus can be isolated stably within 48 hours by using the virus sampling kit at 2-8 ℃ or room temperature. |
Transport stability guaranteed | Safe and residue-free by continuous sterilization by irradiation |
The tube dies are independently developed through cooperation with structural experts to prevent sample leakage and guarantee transport stability. | The expensive sterilization by irradiation is used to guarantee the safety of operators with sterilization integrity. |
Product formulation designed to eliminate contamination | High-quality flocked swabs |
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. | YOCON sampling swabs have been structurally studied to ensure the proper arrangement of flock for maximum adsorption and release of samples. |
Product purpose
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 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 | Excellent product performance |
MT0301 series virus sampling products are registered under Class II medical devices in China. | 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 | Higher positive virus isolation rate |
The elution beads are added to the reagent to promote sample release. | The virus can be isolated stably within 48 hours by using the virus sampling kit at 2-8 ℃ or room temperature. |
Transport stability guaranteed | Safe and residue-free by continuous sterilization by irradiation |
The tube dies are independently developed through cooperation with structural experts to prevent sample leakage and guarantee transport stability. | The expensive sterilization by irradiation is used to guarantee the safety of operators with sterilization integrity. |
Product formulation designed to eliminate contamination | High-quality flocked swabs |
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. | YOCON sampling swabs have been structurally studied to ensure the proper arrangement of flock for maximum adsorption and release of samples. |
