GMQ — Antigens, Nontreponemal, All Class II
FDA product code GMQ covers "Antigens, Nontreponemal, All", a Class II medical device regulated under 21 CFR 866.3820. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GMQ
- Device Class
- Class II
- Regulation Number
- 866.3820
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250249 | gold standard diagnostics | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test | October 10, 2025 |
| K201438 | arlington scientific, inc. (asi) | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Ev | October 21, 2020 |
| K182391 | arlington scientific, inc. (asi) | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | November 30, 2018 |
| K173376 | arlington scientific, inc. (asi) | ASI Evolution | June 14, 2018 |
| K150358 | gold standard diagnostics | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test Syste | November 12, 2015 |
| K000687 | beacon biologicals | THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST | June 12, 2000 |
| K993633 | centers for disease control and prevention | SYNTHETIC VDRL ANTIGEN | February 23, 2000 |
| K992124 | avanti polar lipids | AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI | September 20, 1999 |
| K954994 | guardian scientific | TRUST | October 18, 1996 |
| K955136 | remel, l.p | RPR CARD TEST KIT | July 29, 1996 |
| K952802 | biomira diagnostics | VISUWELL REAGIN II | May 23, 1996 |
| K910541 | biokit usa | BIOKIT RPR | October 18, 1991 |
| K904496 | biotrax | CROMATEST SYPHILIS DIAGNOSTIC | July 24, 1991 |
| K900338 | adi diagnostics | VISUWELL(R) REAGIN TEST (MODIFICATION) | April 10, 1990 |
| K880144 | stanbio laboratory | STANBIO SYPHILIS RPR TEST, NO. 1170 | May 23, 1988 |
| K880477 | ampcor | RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | March 30, 1988 |
| K880165 | ampcor | TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA | March 30, 1988 |
| K871252 | advanced polymer systems | RSR CARD TEST | August 6, 1987 |
| K871226 | new horizons diagnostics | SYPHILIS SEROLOGICAL REAGENTS | May 28, 1987 |
| K864731 | ocean scientific | OCEAN SCIENTIFIC VDRL TEST | March 10, 1987 |