SGA — Biothreat Microbial Agent Nucleic Acid Detection Test Class II

FDA Device Classification

Classification Details

Product Code: SGA
Device Class: Class II
Regulation Number: 866.4000
Submission Type
Review Panel: MI
Medical Specialty: Immunology
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K260812	centers for disease control and prevention	Francisella tularensis Real-time PCR Assay	March 30, 2026
K252072	centers for disease control and prevention	Francisella tularensis Real-time PCR assay	September 30, 2025