Product code NPO
- Device name
- Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3045
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K030370 | REDLINE ANTHRAX ALERT TEST | Tetracore, Inc. | 2003-12-09 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| G143TC51230101 | RedLine Alert™ Test Kit | Tetracore, Inc. | 2022-06-15 |