Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974521005698
- Basic UDI-DI Code
- B-06974521005698
- Reference
- SUPF062025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shenzhen Superbio Technology Co.,Ltd.
Additional Description
The kit is used for the in vitro qualitative detection of respiratory syncytial virus (RSV) antigens in human nasopharyngeal swabs and oropharyngeal swabs. For professional use only. This kit is applicable to auxiliary diagnosis of RSV infection. The test results are for clinical reference only and cannot be used solely as the basis for the diagnosis or exclusion of cases.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099002 | RSV - RT & POC |
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