Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2, Respiratory Syncytium, and Influenza A&B Antigen Combined Detection Kit(Latex Method)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-0000128071590BASL
- Basic UDI-DI Code
- B-0000128071590BASL
- Reference
- HWTS-RT152
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
This kit is used for the qualitative detection of SARS-CoV-2, respiratory syncytial virus and influenza A&B antigens in vitro, and can be used for the differential diagnosis of SARS-CoV-2 infection, respiratory syncytial virus infection, and influenza A or B virus infection[1]. The test results are for clinical reference only and cannot be used as the sole basis for diagnosis and treatment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070503 | RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS |
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