Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 Neutralizing Antibody Rapid Qualitative Test
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06933260208814
- Basic UDI-DI Code
- B-06933260208814
- Reference
- BT0201501
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
Additional Description
The SARS-CoV-2 Neutralizing Antibody Rapid Qualitative Test is an in vitro immunoassay for the detection of total neutralizing antibodies to SARS-CoV-2 in human serum or plasma on Biotime FIA Analyzer by fluorescent immunoassay. The SARS-CoV-2 Neutralizing Antibody Rapid Qualitative Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The SARS-CoV-2 Neutralizing Antibody Rapid Qualitative Test should not be used to diagnose acute SARS-CoV-2 infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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