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The Class II Non-Inactivated Virus Collection Kit by YOCON features a pioneering non-inactivated virus sampling tube, proudly holding the distinction as the first of its kind to be registered as a Class II medical device in China. It is expertly crafted for the safe and effective collection and transportation of clinical samples, preserving viral viability for comprehensive analysis.
Non-Inactivated Design: Maintains viral integrity, making it suitable for a broad range of downstream applications requiring live virus.
Broad Viral Compatibility: Effectively collects samples for various viruses, including but not limited to 2019-nCoV, influenza virus, hand-foot-mouth disease, rubella, measles, norovirus, and rotavirus.
Certified Quality: Registered as a Class II medical device in China (MT0301 series), ensuring compliance and reliability.
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 |
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 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. |
Routine Viral Surveillance: Ideal for ongoing monitoring and detection of various respiratory and enteric viruses.
Molecular Diagnostic Testing: Perfectly suited for samples intended for nucleic acid testing (PCR, qPCR), gene sequencing, and other advanced molecular analyses.
Virus Isolation Studies: Essential for applications requiring the isolation and propagation of live viruses.
Immunoassay Procedures: Compatible with immunoassay platforms for antigen or antibody detection from collected samples.
At YOCON BIOTECH COMPANY, we are committed to providing innovative solutions that empower your research and diagnostics. Our Class II Non-Inactivated Virus Collection Kit reflects our dedication to quality, performance, and customer satisfaction. With our expertise, regulatory compliance, and versatile product design, we are your trusted partner in advancing viral detection and research.
The Class II Non-Inactivated Virus Collection Kit by YOCON features a pioneering non-inactivated virus sampling tube, proudly holding the distinction as the first of its kind to be registered as a Class II medical device in China. It is expertly crafted for the safe and effective collection and transportation of clinical samples, preserving viral viability for comprehensive analysis.
Non-Inactivated Design: Maintains viral integrity, making it suitable for a broad range of downstream applications requiring live virus.
Broad Viral Compatibility: Effectively collects samples for various viruses, including but not limited to 2019-nCoV, influenza virus, hand-foot-mouth disease, rubella, measles, norovirus, and rotavirus.
Certified Quality: Registered as a Class II medical device in China (MT0301 series), ensuring compliance and reliability.
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 |
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 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. |
Routine Viral Surveillance: Ideal for ongoing monitoring and detection of various respiratory and enteric viruses.
Molecular Diagnostic Testing: Perfectly suited for samples intended for nucleic acid testing (PCR, qPCR), gene sequencing, and other advanced molecular analyses.
Virus Isolation Studies: Essential for applications requiring the isolation and propagation of live viruses.
Immunoassay Procedures: Compatible with immunoassay platforms for antigen or antibody detection from collected samples.
At YOCON BIOTECH COMPANY, we are committed to providing innovative solutions that empower your research and diagnostics. Our Class II Non-Inactivated Virus Collection Kit reflects our dedication to quality, performance, and customer satisfaction. With our expertise, regulatory compliance, and versatile product design, we are your trusted partner in advancing viral detection and research.
