Panels › Microbiology › Product code LIP · Class 2
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation 866.3830
0510(k)s in 12 months (35 all time)
2recalls in 12 months (18 all time)
16recalls that name a 510(k)
Top companies in LIP
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad Laboratories | 3 | 8 |
| Mercia Diagnostics , Ltd. | 4 | 0 |
| Siemens Healthcare Diagnostics | 2 | 2 |
| DiaSorin, Inc. | 2 | 1 |
| Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 0 | 2 |
| Diagnostic Chemicals, Ltd. (Usa) | 2 | 0 |
| Diamedix Corporation | 0 | 2 |
| Ortho Diagnostic Systems, Inc. | 2 | 0 |
| Phoenix Biotech Corp. | 2 | 0 |
| Pyramid Biological Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 6, 2024 | K241427 | Access Syphilis Beckman Coulter, Inc. | LIP |
| Aug 28, 2024 | K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack Ortho Clinical Diagnostics, GB | LIP |
| Jul 20, 2021 | K211302 | Elecsys Syphilis Roche Diagnostics | LIP |
| May 11, 2017 | K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR C Bio-Rad Laboratories | LIP |
| Jul 28, 2016 | K160910 | Elecsys Syphilis Roche Diagnostics | LIP |
| Jul 5, 2016 | K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set Fujirebio Diagnostics,Inc. | LIP |
| Jun 15, 2016 | K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control Abbott Laboratories | LIP |
| Mar 14, 2012 | K120439 | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG Bio-Rad Laboratories, Inc. | LIP |
| Jan 20, 2012 | K112343 | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS Siemens Healthcare Diagnostics, Inc. | LIP |
| Aug 1, 2011 | K102400 | SYPHILIS HEALTH CHECK Diagnostics Direct, LLC | LIP |
| Feb 10, 2011 | K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM Zeus Scientific, Inc. | LIP |
| Oct 1, 2010 | K093837 | ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM Zeus Scientific, Inc. (Zeus) | LIP |
| Dec 16, 2009 | K091361 | IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM Siemens Healthcare Diagnostics | LIP |
| Mar 19, 2007 | K063866 | BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories | LIP |
| Aug 10, 2006 | K050590 | ENZY-WELL SYPHILIS IGG, MODEL 91106 Diesse Diagnostica Senese S.P.A. | LIP |
| Aug 7, 2006 | K053570 | TREP-SURE TREPONEMAL ANTIBODY EIA Phoenix Biotech Corp. | LIP |
| Jul 31, 2006 | K061247 | DIASORIN LIAISON TREPONEMA ASSAY DiaSorin, Inc. | LIP |
| Jan 24, 2002 | K014233 | CAPTIAM SYPHILIS-G ASSAY Trinity Biotech, Plc, IE | LIP |
| Nov 29, 2000 | K001525 | CAPTIA SYPHILIS-G ELISA TEST SYSTEM Trinity Biotech, Plc | LIP |
| Oct 19, 2000 | K001552 | TREPCHEK TREPONEMAL ANTIBODY EIA Phoenix Biotech Corp. | LIP |
| Dec 16, 1999 | K992552 | COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY DiaSorin, Inc. | LIP |
| Jun 24, 1996 | K961317 | SYPHILIS IGM HUMAN SERUM CONTROLS Pyramid Biological Corp. | LIP |
| Jun 17, 1996 | K960493 | SYPHILIS IGG HUMAN SERUM CONTROLS Pyramid Biological Corp. | LIP |
| Jul 11, 1995 | K932453 | VISUWELL SYPHILIS ANTIBODY Biomira Diagnostics, Inc., CA | LIP |
| Jun 24, 1991 | K910487 | VISUWELL SYPHILIS ANTIGEN Adi Diagnostics, Inc., CA | LIP |
| Jan 8, 1991 | K895964 | DCL SYPHILIS-M CATALOG NO. 600-80 Diagnostic Chemicals, Ltd. (Usa) | LIP |
| Dec 26, 1990 | K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION Mercia Diagnostics , Ltd., GB | LIP |
| Dec 26, 1990 | K895965 | DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 Diagnostic Chemicals, Ltd. (Usa) | LIP |
| Mar 8, 1990 | K900654 | MODIFIED CAPTIA(R) SYPHILIS-M Mercia Diagnostics , Ltd., GB | LIP |
| Dec 22, 1988 | K883939 | ORTHO* SYPHILIS-G ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LIP |
| Dec 22, 1988 | K883938 | ORTHO* SYPHILIS-M ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LIP |
| Aug 4, 1988 | K881425 | CAPTIA(R) SYPHILIS-G Mercia Diagnostics , Ltd., GB | LIP |
| Aug 7, 1987 | K871548 | CAPTIA(R) SYPHILIS-M Mercia Diagnostics , Ltd., GB | LIP |
| Jul 2, 1985 | K850329 | CORDIA S4 -TREPONEMA PALLIDUM Cordis Corp. | LIP |
| Jun 10, 1982 | K820934 | SYPHILIS BIO-ENZABEAD KIT Biometics Laboratory Products | LIP |
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