GMQ

Product Code: GMQ


Products Classified as GMQ

3168Antigens, Nontreponemal, AllTreponema Pallidum Nontreponemal Test Reagents.

Total Product Life Cycle (TPLC) Devices

3168Antigens, Nontreponemal, AllTreponema Pallidum Nontreponemal Test Reagents.

Pre-market Notifications for GMQ

BK200488Antigens, Nontreponemal, AllArlington Scientific, Inc.
K201438ASI Automated RPR (rapid Plasma Reagin) Test For Syphilis, For Use On The ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (ASI)
K182391ASI Automated ASI RPR Test For Syphilis On The ASI EvolutionArlington Scientific, Inc. (ASI)
K173376ASI EvolutionArlington Scientific, Inc. (ASI)
BK170114510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Arlington Scientific, Inc.
K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGOLD STANDARD DIAGNOSTICS
K000687THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TESTBEACON BIOLOGICALS, INC.
K993633SYNTHETIC VDRL ANTIGENCENTERS FOR DISEASE CONTROL AND PREVENTION
K992124AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTIAVANTI POLAR LIPIDS, INC.
K955136RPR CARD TEST KITREMEL, L.P.
K954994TRUSTGUARDIAN SCIENTIFIC, CORP.
K952802VISUWELL REAGIN IIBIOMIRA DIAGNOSTICS, INC.
K910541BIOKIT RPRBIOKIT USA, INC.
K904496CROMATEST SYPHILIS DIAGNOSTICBIOTRAX, INC.
K900338VISUWELL(R) REAGIN TEST (MODIFICATION)ADI DIAGNOSTICS, INC.

Global Unique Device Identification Database

00382902756927ANTIGENS, NONTREPONEMAL, ALL
00382902755395ANTIGENS, NONTREPONEMAL, ALL
00382902752394ANTIGENS, NONTREPONEMAL, ALL
00382902751304ANTIGENS, NONTREPONEMAL, ALL
00382902751151ANTIGENS, NONTREPONEMAL, ALL
00382902751106ANTIGENS, NONTREPONEMAL, ALL
00382902750055ANTIGENS, NONTREPONEMAL, ALL
00382902744498ANTIGENS, NONTREPONEMAL, ALL
00382902407652ANTIGENS, NONTREPONEMAL, ALL
00382902407645ANTIGENS, NONTREPONEMAL, ALL
00628055726012Antigens, Nontreponemal, All
00628055726005Antigens, Nontreponemal, All
00695684365004Antigens, Nontreponemal, All
00657498001301Antigens, Nontreponemal, All
00657498001295Antigens, Nontreponemal, All

Maude Adverse Events

BD MACRO-VUE? RPR CARD ANTIGEN SUSPENSIONBD CARIBE, LTD2017-11-27
RPR CARD TEST KIT NO. 110BD CARIBE, LTD.2011-10-11
CAPTURE-SIMMUCOR, INC.2008-11-13
CAPTURE-SIMMUCOR, INC.2008-07-07
CAPTURE-SIMMUCOR, INC.2007-09-12
SCIMEDX FTA DS8400SCIMEDX2007-06-27
CAPTURE-SIMMUCOR, INC.2007-04-13
CAPTURE-SIMMUCOR, INC.2006-08-03
CAPTURE-SIMMUCOR, INC.2006-07-24
CAPTIA SYPHILIS IGGTRINITY BIOTECH2002-08-15

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