DeviceClearance

Product code SGA— Immunology

Francisella tularensis Real-time PCR Assay

Classification name
Biothreat Microbial Agent Nucleic Acid Detection Test
Device class
Class 2
Regulation
21 CFR 866.4000
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SGA under 21 CFR 866.4000, via openFDA

Market context for product code SGA

FDA has cleared 2 devices under product code SGA between 2025 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SGA

Recent clearances under product code SGA

Data sourced from openFDA. This site is unofficial and independent of the FDA.