Product code SGA
- Device name
- Biothreat Microbial Agent Nucleic Acid Detection Test
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.4000
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agentassociated nucleic acids in human clinical specimens.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | 2026-03-30 |
| K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | 2025-09-30 |