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510(k) K252072

Francisella tularensis Real-time PCR assay by Centers For Disease Control and Prevention — Product Code SGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2025
Date Received
July 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biothreat Microbial Agent Nucleic Acid Detection Test
Device Class
Class II
Regulation Number
866.4000
Review Panel
MI
Submission Type

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.

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