Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Human Papillomavirus（HPV）DNA Diagnostic Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06973685471318
- Basic UDI-DI Code
- B-06973685471318
- Reference
- 3000000000366
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- 3D Biomedicine Science & Technology Co., Limited
Additional Description
Human Papillomavirus（HPV）DNA Diagnostic Kit is a real-time polymerase chain reaction (qPCR) test intended for qualitative detection of DNA from 14 high-risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 in cervical specimens. The assay specifically identifies HPV genotypes 16 and 18 while concurrently detecting the other high risk genotypes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041002 | SCREENING HIGH-RISK HPV - NA REAGENTS |
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