NRL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3045
- Medical specialty
- Microbiology
- FDA definition
- The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax.
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| Record | Firm | Date |
|---|---|---|
| QUICKELISA ANTHRAX-PA KIT (K040407) | Immunetics, Inc. | 2004-06-03 |
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