510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SGAClass II

Biothreat Microbial Agent Nucleic Acid Detection Test

21 CFR 866.4000 / Immunology
FDA source (opens on fda.gov)

SGA is the FDA product code for Biothreat Microbial Agent Nucleic Acid Detection Test, a class II device type, regulated under 21 CFR 866.4000. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SGA
Device name
Biothreat Microbial Agent Nucleic Acid Detection Test
FDA 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.
Regulation
21 CFR 866.4000
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SGA

By decision year
2 clearances under product code SGA with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGA by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code SGA
Applicants holding the most 510(k) clearances under product code SGA
ApplicantClearances
Centers for Disease Control and Prevention2

Companies listing this code with FDA

Companies whose registered establishments list this code