LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Class II
FDA product code LIP covers "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum", a Class II medical device regulated under 21 CFR 866.3830. 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
- LIP
- Device Class
- Class II
- Regulation Number
- 866.3830
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241427 | beckman coulter | Access Syphilis | September 6, 2024 |
| K241534 | ortho clinical diagnostics | VITROS Immunodiagnostic Products Syphilis Reagent Pack | August 28, 2024 |
| K211302 | roche diagnostics | Elecsys Syphilis | July 20, 2021 |
| K170413 | bio-rad laboratories | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator | May 11, 2017 |
| K160910 | roche diagnostics | Elecsys Syphilis | July 28, 2016 |
| K153145 | fujirebio diagnostics | Lumipulse G TP-N Immunoreaction Cartridge Set | July 5, 2016 |
| K153730 | abbott laboratories | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphi | June 15, 2016 |
| K120439 | bio-rad laboratories | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG | March 14, 2012 |
| K112343 | siemens healthcare diagnostics | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS | January 20, 2012 |
| K102400 | diagnostics direct | SYPHILIS HEALTH CHECK | August 1, 2011 |
| K102283 | zeus scientific | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | February 10, 2011 |
| K093837 | zeus scientific, inc. (zeus) | ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM | October 1, 2010 |
| K091361 | siemens healthcare diagnostics | IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM | December 16, 2009 |
| K063866 | bio-rad laboratories | BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | March 19, 2007 |
| K050590 | diesse diagnostica senese | ENZY-WELL SYPHILIS IGG, MODEL 91106 | August 10, 2006 |
| K053570 | phoenix biotech | TREP-SURE TREPONEMAL ANTIBODY EIA | August 7, 2006 |
| K061247 | diasorin | DIASORIN LIAISON TREPONEMA ASSAY | July 31, 2006 |
| K014233 | trinity biotech | CAPTIAM SYPHILIS-G ASSAY | January 24, 2002 |
| K001525 | trinity biotech | CAPTIA SYPHILIS-G ELISA TEST SYSTEM | November 29, 2000 |
| K001552 | phoenix biotech | TREPCHEK TREPONEMAL ANTIBODY EIA | October 19, 2000 |