Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
OTHER HPV - NA REAGENTS
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06959094211073
- Basic UDI-DI Code
- B-06959094211073
- Reference
- 8.01.25803X048E
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit a real-time PCR assay for qualitative detection of 19 high-risk HPV DNA (HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, and 82) and two low-risk HPV DNA (HPV 6 and 11) in cervical exfoliated cells and urogenital tract secretion. The kit is intended to access the high risk HPV DNA and aid in cervical cancer screening, early diagnostics and treatment. The kit is for in vitro diagnostic use, and intended to be used by trained professionals in a laboratory environment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041005 | OTHER HPV - NA REAGENTS |
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