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Biothreat Microbial Agent Nucleic Acid Detection Test

SGA · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.4000

Classification

FDA Product Code
SGA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.4000
Review panel
MI
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
2
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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