FDA product code NRL: Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
NRL is the FDA product code for enzyme linked immunoabsorbent assay, antibody, b. anthracis. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under NRL. The average 510(k) review took 107 days (median 107).
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.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis |
| Device class | Class II |
| Regulation | 21 CFR 866.3045 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NRL clearance
Top NRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunetics, Inc. | 1 | 2004-06-03 |
Most recent NRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040407 | Immunetics, Inc. | QUICKELISA ANTHRAX-PA KIT | 2004-06-03 | 107 |
Recalls for NRL devices
openFDA lists no recalls for product code NRL.
Frequently asked questions
What is FDA product code NRL?
NRL is the FDA product code for enzyme linked immunoabsorbent assay, antibody, b. anthracis. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel.
What device class is NRL?
Class II, regulation 21 CFR 866.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRL?
Across 1 cleared submissions the average was 107 days from receipt to decision (median 107).
Which companies have the most NRL clearances?
Immunetics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NRL
- Run a recall and safety report across every NRL manufacturer
- Watch product code NRL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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