NRL — Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis Class II
FDA product code NRL covers "Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis", a Class II medical device regulated under 21 CFR 866.3045. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NRL
- Device Class
- Class II
- Regulation Number
- 866.3045
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040407 | immunetics | QUICKELISA ANTHRAX-PA KIT | June 3, 2004 |