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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, hiv detection
510(k) Number BK231015
Tradename Reveal G4 Rapid HIV-1/2 Antibody Test
Device Name Test, HIV Detection
Original Applicant
MedMira Laboratories Inc.
155 chain lake drive
suite 1
halifax,  07  Canada,  B3S 1B3,  CANADA
Regulation Number866.3956
Classification Product Code
Date Received09/25/2023
Decision Date 12/13/2023
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No