Product code GMQ— Microbiology

FDA has cleared 32 devices under product code GMQ between 1981 and 2025, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20201 clearance
• 20182 clearances
• 20151 clearance
• 20002 clearances
• 19991 clearance
• 19963 clearances
• 19912 clearances
• 19901 clearance
• 19883 clearances
• 19873 clearances
• 19861 clearance
• 19851 clearance
• 19842 clearances
• 19832 clearances

• Oxoid U.S.A., Inc.3 clearances
• Arlington Scientific, Inc. (Asi)3 clearances
• Emd Chemicals, Inc.2 clearances
• Ampcor, Inc.2 clearances
• Technicon Instruments Corp.1 clearance
• Syn-Kit, Inc.1 clearance
• Stanbio Laboratory1 clearance
• Remel, L.P.1 clearance
• Preco, Inc.1 clearance
• Ocean Scientific, Inc.1 clearance

• K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC·2025-10-10
• K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis AnalyzerArlington Scientific, Inc. (Asi)·2020-10-21
• K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionArlington Scientific, Inc. (Asi)·2018-11-30
• K173376 — ASI EvolutionArlington Scientific, Inc. (Asi)·2018-06-14
• K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics·2015-11-12
• K000687 — THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TESTBeacon Biologicals, Inc.·2000-06-12
• K993633 — SYNTHETIC VDRL ANTIGENCenters for Disease Control and Prevention·2000-02-23
• K992124 — AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTIAvanti Polar Lipids, Inc.·1999-09-20
• K954994 — TRUSTGuardian Scientific, Corp.·1996-10-18
• K955136 — RPR CARD TEST KITRemel, L.P.·1996-07-29
• K952802 — VISUWELL REAGIN IIBiomira Diagnostics, Inc.·1996-05-23
• K910541 — BIOKIT RPRBiokit USA, Inc.·1991-10-18
• K904496 — CROMATEST SYPHILIS DIAGNOSTICBiotrax, Inc.·1991-07-24
• K900338 — VISUWELL(R) REAGIN TEST (MODIFICATION)Adi Diagnostics, Inc.·1990-04-10
• K880144 — STANBIO SYPHILIS RPR TEST, NO. 1170Stanbio Laboratory·1988-05-23
• K880165 — TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMAAmpcor, Inc.·1988-03-30
• K880477 — RPR TEST FOR SYPHILIS IN SERUM OR PLASMAAmpcor, Inc.·1988-03-30
• K871252 — RSR CARD TESTAdvanced Polymer Systems, Inc.·1987-08-06
• K871226 — SYPHILIS SEROLOGICAL REAGENTSNew Horizons Diagnostics Co.·1987-05-28
• K864731 — OCEAN SCIENTIFIC VDRL TESTOcean Scientific, Inc.·1987-03-10
• K863368 — SYPH-TRUSTI.A.F. Production, Inc.·1986-12-12
• K852751 — TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TESTPreco, Inc.·1985-08-20
• K842541 — RAPID PLASMA REAGIN CARD TESTClinical Sciences, Inc.·1984-07-26
• K834149 — AUTOGROUPER 16C SYS AUTOMATED REAGTechnicon Instruments Corp.·1984-03-09
• K832479 — TRUST RPR CARD TEST #65144Emd Chemicals, Inc.·1983-09-12
• K832480 — TRUST RPR TITRATION CARD TEST #65145Emd Chemicals, Inc.·1983-09-12
• K822661 — RAPID REAGIN CARD TESTOxoid U.S.A., Inc.·1982-09-21
• K822662 — REAGIN ANTIGEN SUSPENSIONOxoid U.S.A., Inc.·1982-09-21
• K820567 — TREP CARD EIKENSyn-Kit, Inc.·1982-04-14
• K812894 — VDRL CARBON ANTIGENOxoid U.S.A., Inc.·1981-11-06
• K811152 — DADE RPR CARD TESTAmerican Dade·1981-05-15
• K810658 — RPR CARD TEST SYSTEMBeckman Instruments, Inc.·1981-03-31