Antigens, Nontreponemal, All
FDA product code GMQ · Class II (moderate risk) · 21 CFR 866.3820 · Microbiology
32510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Oxoid U.S.A., Inc. 3
- Arlington Scientific, Inc. (Asi) 3
- Gold Standard Diagnostics 2
- Emd Chemicals, Inc. 2
- Ampcor, Inc. 2
- New Horizons Diagnostics Co. 1
- Remel, L.P. 1
- Biomira Diagnostics, Inc. 1
- Biokit USA, Inc. 1
- Biotrax, Inc. 1
- Adi Diagnostics, Inc. 1
- Stanbio Laboratory 1
- Advanced Polymer Systems, Inc. 1
- Beckman Instruments, Inc. 1
- Ocean Scientific, Inc. 1
- I.A.F. Production, Inc. 1
- Preco, Inc. 1
- Clinical Sciences, Inc. 1
- Technicon Instruments Corp. 1
- Syn-Kit, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics, LLC | 10/10/2025SE |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…GMQ · Traditional | Arlington Scientific, Inc. (Asi) | 10/21/2020SE |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionGMQ · Traditional | Arlington Scientific, Inc. (Asi) | 11/30/2018SE |
| K173376 | ASI EvolutionGMQ · Traditional | Arlington Scientific, Inc. (Asi) | 06/14/2018SE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics | 11/12/2015SE |
| K000687 | The Daya Syphilis Test/The Trust Antigen TestGMQ · Traditional | Beacon Biologicals, Inc. | 06/12/2000SE |
| K993633 | Synthetic VDRL AntigenGMQ · Traditional | Centers for Disease Control and Prevention | 02/23/2000SE |
| K992124 | Avanti Polar Lipids VDRL Antigen Slide Test Kit with 10 X 0.5 ML Ampules, Avanti Polar…GMQ · Traditional | Avanti Polar Lipids, Inc. | 09/20/1999SE |
| K954994 | TrustGMQ · Traditional | Guardian Scientific, Corp. | 10/18/1996SE |
| K955136 | RPR Card Test KitGMQ · Traditional | Remel, L.P. | 07/29/1996SE |
| K952802 | Visuwell Reagin IIGMQ · Traditional | Biomira Diagnostics, Inc. | 05/23/1996SE |
| K910541 | Biokit RPRGMQ · Traditional | Biokit USA, Inc. | 10/18/1991SE |
| K904496 | Cromatest Syphilis DiagnosticGMQ · Traditional | Biotrax, Inc. | 07/24/1991SE |
| K900338 | Visuwell(R) Reagin Test (Modification)GMQ · Traditional | Adi Diagnostics, Inc. | 04/10/1990SE |
| K880144 | Stanbio Syphilis RPR Test, No. 1170GMQ · Traditional | Stanbio Laboratory | 05/23/1988SE |
| K880477 | RPR Test for Syphilis in Serum or PlasmaGMQ · Traditional | Ampcor, Inc. | 03/30/1988SE |
| K880165 | Trust RPR Test for Syphilis in Serum or PlasmaGMQ · Traditional | Ampcor, Inc. | 03/30/1988SE |
| K871252 | RSR Card TestGMQ · Traditional | Advanced Polymer Systems, Inc. | 08/06/1987SE |
| K871226 | Syphilis Serological ReagentsGMQ · Traditional | New Horizons Diagnostics Co. | 05/28/1987SE |
| K864731 | Ocean Scientific VDRL TestGMQ · Traditional | Ocean Scientific, Inc. | 03/10/1987SE |
| K863368 | Syph-TrustGMQ · Traditional | I.A.F. Production, Inc. | 12/12/1986SE |
| K852751 | Tolvidine Red Unheated Serum Syphillis Card TestGMQ · Traditional | Preco, Inc. | 08/20/1985SE |
| K842541 | Rapid Plasma Reagin Card TestGMQ · Traditional | Clinical Sciences, Inc. | 07/26/1984SE |
| K834149 | Autogrouper 16C Sys Automated ReagGMQ · Traditional | Technicon Instruments Corp. | 03/09/1984SE |
| K832480 | Trust RPR Titration Card Test #65145GMQ · Traditional | Emd Chemicals, Inc. | 09/12/1983SE |
| K832479 | Trust RPR Card Test #65144GMQ · Traditional | Emd Chemicals, Inc. | 09/12/1983SE |
| K822662 | Reagin Antigen SuspensionGMQ · Traditional | Oxoid U.S.A., Inc. | 09/21/1982SE |
| K822661 | Rapid Reagin Card TestGMQ · Traditional | Oxoid U.S.A., Inc. | 09/21/1982SE |
| K820567 | Trep Card EikenGMQ · Traditional | Syn-Kit, Inc. | 04/14/1982SE |
| K812894 | VDRL Carbon AntigenGMQ · Traditional | Oxoid U.S.A., Inc. | 11/06/1981SE |
| K811152 | Dade RPR Card TestGMQ · Traditional | American Dade | 05/15/1981SE |
| K810658 | RPR Card Test SystemGMQ · Traditional | Beckman Instruments, Inc. | 03/31/1981SE |