SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA),
Basic Information
- Primary DI
- 06971042229626
- Basic UDI-DI Code
- B-06971042229626
- Reference
- EL-0001-96
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
Additional Description
The SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA) is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of total neutralizing antibodies to SARS-CoV-2 in human serum. The SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA) 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 Neutralization Antibody Detection Kit (ELISA) should not be used to diagnose or exclude acute SARS-CoV-2 infection. Results are for the detection of SARS CoV-2 total neutralizing antibodies. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time neutralizing antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. The sensitivity of the SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA) early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Similar Devices
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