COVID-19 SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
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Basic Information
- Primary DI
- 06970877683009
- Basic UDI-DI Code
- B-06970877683009
- Reference
- 0301
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Kangmei Tianhong Biotech (Beijing) Co., Ltd.
Additional Description
For vitro qualitative detection of Anti-SARS-CoV-2 antibody from serum、plasma and whole blood samples. It is only intended for the supplementary indicator for suspected cases of negative SARS-CoV-2 nucleic acid detection, or combination with nucleic acid detection in the diagnosis of suspected cases. Results from antibody testing should not be used as the sole basis to diagnose or exclude COVID-19. It is not intended for screening in general population. Positive test results need further confirmation. Negative results do not exclude SARS-CoV-2 infection. These kits are for medical use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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