Product code LIP
- Device name
- Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3830
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241427 | Access Syphilis | Beckman Coulter, Inc. | 2024-09-06 |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics | 2024-08-28 |
| K211302 | Elecsys Syphilis | Roche Diagnostics | 2021-07-20 |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | Bio-Rad Laboratories | 2017-05-11 |
| K160910 | Elecsys Syphilis | Roche Diagnostics | 2016-07-28 |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics,Inc. | 2016-07-05 |
| K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control | Abbott Laboratories | 2016-06-15 |
| K120439 | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG | Bio-Rad Laboratories, Inc. | 2012-03-14 |
| K112343 | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| K102400 | SYPHILIS HEALTH CHECK | Diagnostics Direct, LLC | 2011-08-01 |
| K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-02-10 |
| K093837 | ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM | Zeus Scientific, Inc. (Zeus) | 2010-10-01 |
| K091361 | IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM | Siemens Healthcare Diagnostics | 2009-12-16 |
| K063866 | BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2007-03-19 |
| K050590 | ENZY-WELL SYPHILIS IGG, MODEL 91106 | Diesse Diagnostica Senese S.P.A. | 2006-08-10 |
| K053570 | TREP-SURE TREPONEMAL ANTIBODY EIA | Phoenix Biotech Corp. | 2006-08-07 |
| K061247 | DIASORIN LIAISON TREPONEMA ASSAY | DiaSorin, Inc. | 2006-07-31 |
| K014233 | CAPTIAM SYPHILIS-G ASSAY | Trinity Biotech, Plc | 2002-01-24 |
| K001525 | CAPTIA SYPHILIS-G ELISA TEST SYSTEM | Trinity Biotech, Plc | 2000-11-29 |
| K001552 | TREPCHEK TREPONEMAL ANTIBODY EIA | Phoenix Biotech Corp. | 2000-10-19 |
| K992552 | COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY | DiaSorin, Inc. | 1999-12-16 |
| K961317 | SYPHILIS IGM HUMAN SERUM CONTROLS | Pyramid Biological Corp. | 1996-06-24 |
| K960493 | SYPHILIS IGG HUMAN SERUM CONTROLS | Pyramid Biological Corp. | 1996-06-17 |
| K932453 | VISUWELL SYPHILIS ANTIBODY | Biomira Diagnostics, Inc. | 1995-07-11 |
| K910487 | VISUWELL SYPHILIS ANTIGEN | Adi Diagnostics, Inc. | 1991-06-24 |
| K895964 | DCL SYPHILIS-M CATALOG NO. 600-80 | Diagnostic Chemicals, Ltd. (Usa) | 1991-01-08 |
| K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION | Mercia Diagnostics , Ltd. | 1990-12-26 |
| K900654 | MODIFIED CAPTIA(R) SYPHILIS-M | Mercia Diagnostics , Ltd. | 1990-03-08 |
| K883938 | ORTHO* SYPHILIS-M ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1988-12-22 |
| K883939 | ORTHO* SYPHILIS-G ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1988-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590763626 | Access Syphilis Reagent | Beckman Coulter, Inc. | 2025-05-07 |
| 10758750035052 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-09-18 |
| 20758750035059 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-09-18 |
| 03610522207992 | BioPlex | BIO-RAD LABORATORIES, INC. | 2023-07-28 |
| 03610522183692 | BioPlex | BIO-RAD LABORATORIES, INC. | 2023-07-28 |
| 07613336171998 | Elecsys Syphilis | Roche Diagnostics GmbH | 2022-03-15 |
| 07613336171950 | Elecsys Syphilis | Roche Diagnostics GmbH | 2022-03-15 |
| 00607158000083 | DPP HIV-Syphilis | Chembio Diagnostic Systems Inc. | 2020-12-29 |
| 00630414599892 | Atellica IM Syph QC | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00380740138332 | Alinity | Abbott GmbH | 2020-05-29 |
| 05391516746588 | Bio-Stat | CLARK LABORATORIES, INC. | 2019-12-30 |
| 05391516747424 | Phoenix Biotech | CLARK LABORATORIES, INC. | 2019-12-30 |
| 05391516746892 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746861 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746687 | Bio-Rad | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746908 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516747226 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 05391516746847 | Phoenix Biotech | CLARK LABORATORIES, INC. | 2019-08-06 |
| 05391516746915 | Phoenix Biotech | CLARK LABORATORIES, INC. | 2019-08-06 |
| 03610522015597 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2018-02-05 |
| 03610522004980 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2018-02-05 |
| 03610520992692 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-07-25 |
| 03610520653012 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-07-25 |
| 03610520138267 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-07-25 |
| 04015630940356 | Elecsys Syphilis | Roche Diagnostics GmbH | 2017-05-10 |
| 04015630934881 | Elecsys Syphilis | Roche Diagnostics GmbH | 2016-10-28 |
| 08056771100618 | LIAISON® Treponema Assay | DIASORIN SPA | 2016-09-24 |
| 00380740117122 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740117115 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740103538 | ARCHITECT | Abbott GmbH | 2016-09-09 |