LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Class II
FDA Device Classification
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 |