BEUDAMED
    Product Code: LIP FDA class 2 21 CFR 866.3830

    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

    Microbiology

    An enzyme-linked immunosorbent assay (ELISA) for Treponema pallidum is a laboratory diagnostic test that detects antibodies to Treponema pallidum, the causative agent of syphilis, in patient serum, supporting the serological diagnosis and confirmation of syphilitic infection. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIP and is regulated under 21 CFR 866.3830 within the Microbiology specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    35
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    24
    Years Active
    42

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    Basic Information

    Product Code
    LIP
    Device Class
    FDA class 2
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 35 510(k) clearances via K numbers.

    K Number Device Name
    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
    K904524 CAPTIA(R) SYPHILIS M, MODIFICATION
    K895965 DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
    K900654 MODIFIED CAPTIA(R) SYPHILIS-M
    K883939 ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
    K883938 ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
    K881425 CAPTIA(R) SYPHILIS-G
    K871548 CAPTIA(R) SYPHILIS-M
    K850329 CORDIA S4 -TREPONEMA PALLIDUM
    K820934 SYPHILIS BIO-ENZABEAD KIT

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.