Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Device Code: 3610
Product Code(s):
NRL 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.
Device Classification Information
| Device Type ID | 3610 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | NRL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3610 |
| Device | Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis |
| Product Code | NRL |
TPLC Last Update: 2019-04-02 20:33:10