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FDA PRODUCT CODE · CLASS II

SGA — Biothreat Microbial Agent Nucleic Acid Detection Test

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.4000
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K260812Centers for Disease Control and Prevention · 510k2026-03-30
K252072Centers for Disease Control and Prevention · 510k2025-09-30

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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