Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SCREENING HIGH-RISK HPV - NA REAGENTS
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
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Basic Information
- Primary DI
- 06950917910579
- Basic UDI-DI Code
- B-06950917910579
- Reference
- C011938
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Triplex International Biosciences (China) Co., LTD.
Additional Description
The kit is suitable for the in vitro qualitative detection of HPV subtypes 16 and 18 nucleic acid in female cervical samples. This kit has not been clinically tested and cannot be used for cervical screening. A positive result can only indicate single or mixed HPV16 and 18 infection in clinical samples and cannot distinguish the two. The results are for clinical reference only and should not be used as the sole basis for disease diagnosis or exclusion.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041002 | SCREENING HIGH-RISK HPV - NA REAGENTS |
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