NPO — Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody Class II
FDA product code NPO covers "Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody", 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
- NPO
- Device Class
- Class II
- Regulation Number
- 866.3045
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K030370 | tetracore | REDLINE ANTHRAX ALERT TEST | December 9, 2003 |