Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart D — Serological Reagents](/submissions/IM/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.4000](/submissions/IM/subpart-d%E2%80%94serological-reagents/866.4000) → SGA — Biothreat Microbial Agent Nucleic Acid Detection Test

# SGA · Biothreat Microbial Agent Nucleic Acid Detection Test

_Immunology · 21 CFR 866.4000 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/SGA

## Overview

- **Product Code:** SGA
- **Device Name:** Biothreat Microbial Agent Nucleic Acid Detection Test
- **Regulation:** [21 CFR 866.4000](/submissions/IM/subpart-d%E2%80%94serological-reagents/866.4000)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260812](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/SGA/K260812.md) | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | Mar 30, 2026 | SESE |
| [K252072](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/SGA/K252072.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/SGA](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/SGA)

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