FDA product code NPO: Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
NPO is the FDA product code for kit, immunochromatographic, bacillus anthracis differential antibody. 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 NPO. The average 510(k) review took 308 days (median 308).
Definition
A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
Classification
| Field | Value |
|---|---|
| Device name | Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody |
| 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 NPO clearance
Top NPO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tetracore, Inc. | 1 | 2003-12-09 |
Most recent NPO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030370 | Tetracore, Inc. | REDLINE ANTHRAX ALERT TEST | 2003-12-09 | 308 |
Recalls for NPO devices
openFDA lists no recalls for product code NPO.
Frequently asked questions
What is FDA product code NPO?
NPO is the FDA product code for kit, immunochromatographic, bacillus anthracis differential antibody. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel.
What device class is NPO?
Class II, regulation 21 CFR 866.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPO?
Across 1 cleared submissions the average was 308 days from receipt to decision (median 308).
Which companies have the most NPO clearances?
Tetracore, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NPO
- Run a recall and safety report across every NPO manufacturer
- Watch product code NPO 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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