SGA · Biothreat Microbial Agent Nucleic Acid Detection Test
Immunology · 21 CFR 866.4000 · Class 2
Overview
| Product Code | SGA |
|---|---|
| Device Name | Biothreat Microbial Agent Nucleic Acid Detection Test |
| Regulation | 21 CFR 866.4000 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | Mar 30, 2026 | SESE |
| K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | Sep 30, 2025 | SESE |
Top Applicants
- Centers for Disease Control and Prevention — 2 clearances
