Panels › Microbiology › Product code GMQ · Class 2
Antigens, Nontreponemal, All
Regulation 866.3820
0510(k)s in 12 months (32 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GMQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Arlington Scientific, Inc. (Asi) | 3 | 0 |
| Oxoid U.S.A., Inc. | 3 | 0 |
| Ampcor, Inc. | 2 | 0 |
| Emd Chemicals, Inc. | 2 | 0 |
| Gold Standard Diagnostics | 2 | 0 |
| Adi Diagnostics, Inc. | 1 | 0 |
| Advanced Polymer Systems, Inc. | 1 | 0 |
| American Dade | 1 | 0 |
| Avanti Polar Lipids, Inc. | 1 | 0 |
| Beacon Biologicals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 10, 2025 | K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System Gold Standard Diagnostics, LLC | GMQ |
| Oct 21, 2020 | K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer Arlington Scientific, Inc. (Asi) | GMQ |
| Nov 30, 2018 | K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution Arlington Scientific, Inc. (Asi) | GMQ |
| Jun 14, 2018 | K173376 | ASI Evolution Arlington Scientific, Inc. (Asi) | GMQ |
| Nov 12, 2015 | K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System Gold Standard Diagnostics | GMQ |
| Jun 12, 2000 | K000687 | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST Beacon Biologicals, Inc. | GMQ |
| Feb 23, 2000 | K993633 | SYNTHETIC VDRL ANTIGEN Centers for Disease Control and Prevention | GMQ |
| Sep 20, 1999 | K992124 | AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI Avanti Polar Lipids, Inc. | GMQ |
| Oct 18, 1996 | K954994 | TRUST Guardian Scientific, Corp. | GMQ |
| Jul 29, 1996 | K955136 | RPR CARD TEST KIT Remel, L.P. | GMQ |
| May 23, 1996 | K952802 | VISUWELL REAGIN II Biomira Diagnostics, Inc., CA | GMQ |
| Oct 18, 1991 | K910541 | BIOKIT RPR Biokit USA, Inc., ES | GMQ |
| Jul 24, 1991 | K904496 | CROMATEST SYPHILIS DIAGNOSTIC Biotrax, Inc. | GMQ |
| Apr 10, 1990 | K900338 | VISUWELL(R) REAGIN TEST (MODIFICATION) Adi Diagnostics, Inc., CA | GMQ |
| May 23, 1988 | K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 Stanbio Laboratory | GMQ |
| Mar 30, 1988 | K880477 | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA Ampcor, Inc. | GMQ |
| Mar 30, 1988 | K880165 | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA Ampcor, Inc. | GMQ |
| Aug 6, 1987 | K871252 | RSR CARD TEST Advanced Polymer Systems, Inc. | GMQ |
| May 28, 1987 | K871226 | SYPHILIS SEROLOGICAL REAGENTS New Horizons Diagnostics Co. | GMQ |
| Mar 10, 1987 | K864731 | OCEAN SCIENTIFIC VDRL TEST Ocean Scientific, Inc. | GMQ |
| Dec 12, 1986 | K863368 | SYPH-TRUST I.A.F. Production, Inc., CA | GMQ |
| Aug 20, 1985 | K852751 | TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST Preco, Inc. | GMQ |
| Jul 26, 1984 | K842541 | RAPID PLASMA REAGIN CARD TEST Clinical Sciences, Inc. | GMQ |
| Mar 9, 1984 | K834149 | AUTOGROUPER 16C SYS AUTOMATED REAG Technicon Instruments Corp. | GMQ |
| Sep 12, 1983 | K832480 | TRUST RPR TITRATION CARD TEST #65145 Emd Chemicals, Inc. | GMQ |
| Sep 12, 1983 | K832479 | TRUST RPR CARD TEST #65144 Emd Chemicals, Inc. | GMQ |
| Sep 21, 1982 | K822662 | REAGIN ANTIGEN SUSPENSION Oxoid U.S.A., Inc. | GMQ |
| Sep 21, 1982 | K822661 | RAPID REAGIN CARD TEST Oxoid U.S.A., Inc. | GMQ |
| Apr 14, 1982 | K820567 | TREP CARD EIKEN Syn-Kit, Inc. | GMQ |
| Nov 6, 1981 | K812894 | VDRL CARBON ANTIGEN Oxoid U.S.A., Inc. | GMQ |
| May 15, 1981 | K811152 | DADE RPR CARD TEST American Dade | GMQ |
| Mar 31, 1981 | K810658 | RPR CARD TEST SYSTEM Beckman Instruments, Inc. | GMQ |
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