Eu Ivdr
Eu Ivd Class C
On The Market
🇨🇳 China
EasyNAT HSV 1&2 Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240152
- Basic UDI-DI Code
- 697349224U2030042C000FJ
- Reference
- U20304
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Ustar Biotechnologies (Hangzhou) Ltd.
Additional Description
This kit is an automated, in vitro nucleic acid amplification test used for the qualitative detection of herpes simplex virus (HSV) type I and type II deoxyribonucleic acid (DNA) in clinician-collected herpes fluid samples in symptomatic patients, for auxiliary diagnosis of HSV type I and type II infection. This kit is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040311 | HSV - NA REAGENTS |
Available In Countries
🇫🇷 France
🇳🇱 Netherlands
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