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510(k) K131936

JBAIDS TULAREMIA DETECTION KIT by Biofire Diagnostics, Inc. — Product Code OEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2013
Date Received
June 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Device Class
Class II
Regulation Number
866.3280
Review Panel
MI
Submission Type

To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.

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Other clearances for product code OEH

  • K072547 — JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (December 19, 2007)