Product code GMQ
- Device name
- Antigens, Nontreponemal, All
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3820
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | 2025-10-10 |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | Arlington Scientific, Inc. (Asi) | 2020-10-21 |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-11-30 |
| K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-06-14 |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics | 2015-11-12 |
| K000687 | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST | Beacon Biologicals, Inc. | 2000-06-12 |
| K993633 | SYNTHETIC VDRL ANTIGEN | Centers 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, AVANTI | Avanti Polar Lipids, Inc. | 1999-09-20 |
| K954994 | TRUST | Guardian Scientific, Corp. | 1996-10-18 |
| K955136 | RPR CARD TEST KIT | Remel, L.P. | 1996-07-29 |
| K952802 | VISUWELL REAGIN II | Biomira Diagnostics, Inc. | 1996-05-23 |
| K910541 | BIOKIT RPR | Biokit USA, Inc. | 1991-10-18 |
| K904496 | CROMATEST SYPHILIS DIAGNOSTIC | Biotrax, Inc. | 1991-07-24 |
| K900338 | VISUWELL(R) REAGIN TEST (MODIFICATION) | Adi Diagnostics, Inc. | 1990-04-10 |
| K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 | Stanbio Laboratory | 1988-05-23 |
| K880165 | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | Ampcor, Inc. | 1988-03-30 |
| K880477 | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | Ampcor, Inc. | 1988-03-30 |
| K871252 | RSR CARD TEST | Advanced Polymer Systems, Inc. | 1987-08-06 |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | New Horizons Diagnostics Co. | 1987-05-28 |
| K864731 | OCEAN SCIENTIFIC VDRL TEST | Ocean Scientific, Inc. | 1987-03-10 |
| K863368 | SYPH-TRUST | I.A.F. Production, Inc. | 1986-12-12 |
| K852751 | TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST | Preco, Inc. | 1985-08-20 |
| K842541 | RAPID PLASMA REAGIN CARD TEST | Clinical Sciences, Inc. | 1984-07-26 |
| K834149 | AUTOGROUPER 16C SYS AUTOMATED REAG | Technicon Instruments Corp. | 1984-03-09 |
| K832479 | TRUST RPR CARD TEST #65144 | Emd Chemicals, Inc. | 1983-09-12 |
| K832480 | TRUST RPR TITRATION CARD TEST #65145 | Emd Chemicals, Inc. | 1983-09-12 |
| K822662 | REAGIN ANTIGEN SUSPENSION | Oxoid U.S.A., Inc. | 1982-09-21 |
| K822661 | RAPID REAGIN CARD TEST | Oxoid U.S.A., Inc. | 1982-09-21 |
| K820567 | TREP CARD EIKEN | Syn-Kit, Inc. | 1982-04-14 |
| K812894 | VDRL CARBON ANTIGEN | Oxoid U.S.A., Inc. | 1981-11-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850021758233 | RPR Carbon Antigen | KSL Biomedical, Inc. | 2026-04-13 |
| B350GSD011600DIL0 | GSD RPR Diluent | Gold Standard Diagnostics Corporation | 2025-10-16 |
| 03610522015597 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2018-02-05 |
| 03610520992692 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-07-25 |
| 03610520138267 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-07-25 |
| 10722355001811 | Detector RPR | Immunostics Company, Inc | 2016-12-03 |
| 10722355001804 | Detector RPR | Immunostics Company, Inc | 2016-12-03 |
| 10722355001798 | Detector RPR | Immunostics Company, Inc | 2016-12-03 |
| 10722355001781 | Detector RPR | Immunostics Company, Inc | 2016-12-03 |
| 10722355001774 | Detector RPR | Immunostics Company, Inc | 2016-12-03 |
| 10722355001767 | Detector RPR | Immunostics Company, Inc | 2016-12-03 |
| B350GSD341600R0 | Gold Standard Diagnostics RPR Reagent Pack | Gold Standard Diagnostics Corporation | 2016-11-29 |
| 10859035006177 | IMPACT RPR™ PIPETS/STIRRERS 250 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006252 | IMPACT RPR™ 15 WELL TEST CARDS 300 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006184 | IMPACT RPR™ 10 WELL TEST CARDS 50 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006160 | IMPACT RPR™ DISPENSING BOTTLES 10 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006153 | IMPACT RPR™ NEEDLE/SHEATH 10 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006146 | IMPACT RPR™ 30 WELL TEST CARDS 100 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006139 | IMPACT RPR™ 10 WELL TEST CARDS 300 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006122 | IMPACT RPR™ PIPETS/STIRRERS 500 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006115 | IMPACT RPR™ LIQUID CONTROL 3 X 1 ML | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006108 | IMPACT RPR™ DRY CONTROL CARDS 10 EA | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006092 | IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006085 | IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006078 | IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS) | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006061 | IMPACT RPR™ TEST KIT (5000 TESTS) | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006054 | IMPACT RPR™ TEST KIT (500 TESTS) | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006047 | IMPACT RPR™ TEST KIT (150 TESTS) | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 10859035006030 | IMPACT RPR™ TEST KIT (50 TESTS) | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 08426950592327 | Biokit RPR 500 TESTS | BIOKIT, S.A. | 2016-09-23 |