Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208739
- Basic UDI-DI Code
- B-06933260208739
- Reference
- BT1301
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test is intended to qualify the SARS-CoV-2 IgG and IgM antibody in human plasma, serum or whole blood by colloidal gold immunochromatography assay.The test can be used as an aid detection to SARS-CoV-2 infection and thus caused COVID-19 disease.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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