Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
VIROLOGY - RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975977071008
- Basic UDI-DI Code
- B-06975977071008
- Reference
- 600100
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Probe Diagnostic Biotechnology Inc. MF
Additional Description
COVID-19 Antigen Rapid Test Kit is a solid phase immune-chromatographic assay for the in vitro qualitative detection of nucleocapsid protein antigen from 2019 Novel Coronavirus in human nasopharyngeal secretion or oropharyngeal secretion. This test kit provides only a preliminary test result for COVID-19 infection as a clinically-assisted diagnosis. Testing is only limited to professional laboratories.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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