Product code LIP— Microbiology
Elecsys Syphilis
- Classification name
- Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Total cleared
- 35
- First cleared
- Most recent
Market context for product code LIP
FDA has cleared devices under product code LIP between 1982 and 2024, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2021
- 2017
- 2016
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 2002
- 2000
- 1999
- 1996
- 1995
Top applicants under product code LIP
Recent clearances under product code LIP
- K241427 — Access Syphilis
- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
- K211302 — Elecsys Syphilis
- K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
- K160910 — Elecsys Syphilis
- K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set
- K153730 — ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
- K120439 — BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
- K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
- K102400 — SYPHILIS HEALTH CHECK
- K102283 — ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
- K093837 — ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
- K091361 — IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
- K063866 — BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K050590 — ENZY-WELL SYPHILIS IGG, MODEL 91106
- K053570 — TREP-SURE TREPONEMAL ANTIBODY EIA
- K061247 — DIASORIN LIAISON TREPONEMA ASSAY
- K014233 — CAPTIAM SYPHILIS-G ASSAY
- K001525 — CAPTIA SYPHILIS-G ELISA TEST SYSTEM
- K001552 — TREPCHEK TREPONEMAL ANTIBODY EIA
- K992552 — COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
- K961317 — SYPHILIS IGM HUMAN SERUM CONTROLS
- K960493 — SYPHILIS IGG HUMAN SERUM CONTROLS
- K932453 — VISUWELL SYPHILIS ANTIBODY
- K910487 — VISUWELL SYPHILIS ANTIGEN
- K895964 — DCL SYPHILIS-M CATALOG NO. 600-80
- K895965 — DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
- K904524 — CAPTIA(R) SYPHILIS M, MODIFICATION
- K900654 — MODIFIED CAPTIA(R) SYPHILIS-M
- K883938 — ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
- K883939 — ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
- K881425 — CAPTIA(R) SYPHILIS-G
- K871548 — CAPTIA(R) SYPHILIS-M
- K850329 — CORDIA S4 -TREPONEMA PALLIDUM
- K820934 — SYPHILIS BIO-ENZABEAD KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.