Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974521008071
- Basic UDI-DI Code
- B-06974521008071
- Reference
- SUPG290025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shenzhen Superbio Technology Co.,Ltd.
Additional Description
Based on immunochromatography assay technology, this kit is used for in vitro qualitative detection of monkeypox virus antigen proteins in swabs of human lesion surfaces and/or exudates. For professional use only. This test provides only a preliminary test result. Therefore, any reactive specimen with the kit must be confirmed with alternative testing method(s) and clinical findings.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
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