Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Monkeypox Virus Antigen Rapid Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06936983148665
- Basic UDI-DI Code
- B-06936983148665
- Reference
- IMXG-402
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
The Monkeypox Virus Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection of monkeypox virus A29L antigen in human serum, plasma, whole blood, rash exudate and throat swab specimens. It is intended for use as an aid in the diagnosis of monkeypox virus infection. Results are for the detection of monkeypox virus antigen. Positive results indicate the presence of monkeypox virus antigen.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
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