Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

FDA product code LIP · 35 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.3830
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1982-06-10 – 2024-09-06

LIP 2024-09-06

Access Syphilis

Applicant Beckman Coulter, Inc.

K number K241427

View details →

LIP 2024-08-28

VITROS Immunodiagnostic Products Syphilis Reagent Pack

Applicant Ortho Clinical Diagnostics

K number K241534

View details →

LIP 2021-07-20

Elecsys Syphilis

Applicant Roche Diagnostics

K number K211302

View details →

LIP 2017-05-11

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set

Applicant Bio-Rad Laboratories

K number K170413

View details →

LIP 2016-07-28

Elecsys Syphilis

Applicant Roche Diagnostics

K number K160910

View details →

LIP 2016-07-05

Lumipulse G TP-N Immunoreaction Cartridge Set

Applicant Fujirebio Diagnostics,Inc.

K number K153145

View details →

LIP 2016-06-15

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

Applicant Abbott Laboratories

K number K153730

View details →

LIP 2012-03-14

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

Applicant Bio-Rad Laboratories, Inc.

K number K120439

View details →

LIP 2012-01-20

TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS

Applicant Siemens Healthcare Diagnostics, Inc.

K number K112343

View details →

LIP 2011-08-01

SYPHILIS HEALTH CHECK

Applicant Diagnostics Direct, LLC

K number K102400

View details →

LIP 2011-02-10

ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K102283

View details →

LIP 2010-10-01

ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM

Applicant Zeus Scientific, Inc. (Zeus)

K number K093837

View details →

LIP 2009-12-16

IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM

Applicant Siemens Healthcare Diagnostics

K number K091361

View details →

LIP 2007-03-19

BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

Applicant Bio-Rad Laboratories

K number K063866

View details →

LIP 2006-08-10

ENZY-WELL SYPHILIS IGG, MODEL 91106

Applicant Diesse Diagnostica Senese S.P.A.

K number K050590

View details →

LIP 2006-08-07

TREP-SURE TREPONEMAL ANTIBODY EIA

Applicant Phoenix Biotech Corp.

K number K053570

View details →

LIP 2006-07-31

DIASORIN LIAISON TREPONEMA ASSAY

Applicant DiaSorin, Inc.

K number K061247

View details →

LIP 2002-01-24

CAPTIAM SYPHILIS-G ASSAY

Applicant Trinity Biotech, Plc

K number K014233

View details →

LIP 2000-11-29

CAPTIA SYPHILIS-G ELISA TEST SYSTEM

Applicant Trinity Biotech, Plc

K number K001525

View details →

LIP 2000-10-19

TREPCHEK TREPONEMAL ANTIBODY EIA

Applicant Phoenix Biotech Corp.

K number K001552

View details →

LIP 1999-12-16

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY

Applicant DiaSorin, Inc.

K number K992552

View details →

LIP 1996-06-24

SYPHILIS IGM HUMAN SERUM CONTROLS

Applicant Pyramid Biological Corp.

K number K961317

View details →

LIP 1996-06-17

SYPHILIS IGG HUMAN SERUM CONTROLS

Applicant Pyramid Biological Corp.

K number K960493

View details →

LIP 1995-07-11

VISUWELL SYPHILIS ANTIBODY

Applicant Biomira Diagnostics, Inc.

K number K932453

View details →

LIP 1991-06-24

VISUWELL SYPHILIS ANTIGEN

Applicant Adi Diagnostics, Inc.

K number K910487

View details →

LIP 1991-01-08

DCL SYPHILIS-M CATALOG NO. 600-80

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K895964

View details →

LIP 1990-12-26

CAPTIA(R) SYPHILIS M, MODIFICATION

Applicant Mercia Diagnostics , Ltd.

K number K904524

View details →

LIP 1990-12-26

DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K895965

View details →

LIP 1990-03-08

MODIFIED CAPTIA(R) SYPHILIS-M

Applicant Mercia Diagnostics , Ltd.

K number K900654

View details →

LIP 1988-12-22

ORTHO* SYPHILIS-G ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K883939

View details →

LIP 1988-12-22

ORTHO* SYPHILIS-M ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K883938

View details →

LIP 1988-08-04

CAPTIA(R) SYPHILIS-G

Applicant Mercia Diagnostics , Ltd.

K number K881425

View details →

LIP 1987-08-07

CAPTIA(R) SYPHILIS-M

Applicant Mercia Diagnostics , Ltd.

K number K871548

View details →

LIP 1985-07-02

CORDIA S4 -TREPONEMA PALLIDUM

Applicant Cordis Corp.

K number K850329

View details →

LIP 1982-06-10

SYPHILIS BIO-ENZABEAD KIT

Applicant Biometics Laboratory Products

K number K820934

View details →