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GMQ — Antigens, Nontreponemal, All Class II

FDA Device Classification

Classification Details

Product Code
GMQ
Device Class
Class II
Regulation Number
866.3820
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K182391arlington scientific, inc. (asi)ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionNovember 30, 2018
K173376arlington scientific, inc. (asi)ASI EvolutionJune 14, 2018
K150358gold standard diagnosticsGold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SysteNovember 12, 2015
K000687beacon biologicalsTHE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TESTJune 12, 2000
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K992124avanti polar lipidsAVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTISeptember 20, 1999
K954994guardian scientificTRUSTOctober 18, 1996
K955136remel, l.pRPR CARD TEST KITJuly 29, 1996
K952802biomira diagnosticsVISUWELL REAGIN IIMay 23, 1996
K910541biokit usaBIOKIT RPROctober 18, 1991
K904496biotraxCROMATEST SYPHILIS DIAGNOSTICJuly 24, 1991
K900338adi diagnosticsVISUWELL(R) REAGIN TEST (MODIFICATION)April 10, 1990
K880144stanbio laboratorySTANBIO SYPHILIS RPR TEST, NO. 1170May 23, 1988
K880165ampcorTRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMAMarch 30, 1988
K880477ampcorRPR TEST FOR SYPHILIS IN SERUM OR PLASMAMarch 30, 1988
K871252advanced polymer systemsRSR CARD TESTAugust 6, 1987
K871226new horizons diagnosticsSYPHILIS SEROLOGICAL REAGENTSMay 28, 1987
K864731ocean scientificOCEAN SCIENTIFIC VDRL TESTMarch 10, 1987