Trinity Biotech USA

FDA Device Registration & Listing · Jamestown, NY, US · Registration 1318354

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1318354
FEI Number
1318354
Entity Name
Trinity Biotech USA
City/State/Country
Jamestown, NY, US
Establishment Address
2823 Girts Rd, Jamestown, NY 14701, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TRINITY BIOTECH, PLC (Owner Number: 9025161)
Owner / Operator Contact Address
2823 Girts Rd, Jamestown, NY 14701, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K941358
PMA Number
N/A

All Registered Proprietary Names

Captia Helicobacter pylori IgG Captia Rubella IgG Captia Syphilis (T. palllidum)-G Captia Mumps IgG Captia Epstein Barr Virus (EBV) VCA IgM BioRad EBV VCA igM Captia PR-3 (c anca) MarDx Borrelia burgdorferi Lyme EIA IgG+IgM Screen Kit Captia Chlamydia IgG Captia Varicella Zoster Virus IgM Captia SS-B (La) Captia Toxoplasma gondii IgM Trinity Biotech ACE Controls Captia Scl-70 Captia Herpes Simplex Virus 1 (HSV 1) IgM Trinity Biotech ACE Calibrator Captia Smith (Sm) Trinity Biotech Uni-Gold Syphilis Treponemal Control Kit Trinity Biotech Uni-Gold Syphilis Treponemal Test Kit Trinity Biotech Captia Syphilis IgM ELISA Test Kit BioRad Syphilis IgM ELISA Test Kit BioRad Syphilis Total Antibody ELISA Test Kit Trinity Biotech Captia Syphilis Total Antibody ELISA Test Kit Captia Syphilis Total Antibody ELISA Test Kit Captia dsDNA Captia Helicobacter pylori IgA Trinity Biotech Uni-Gold H. pylori Antigen Test Kit Trinity Biotech Uni-Gold H. pylori Antigen Control Kit Captia Herpes Simplex Virus 1 (HSV 1) Type Specific IgG MarDx Borrelia burgdorferi Lyme EIA IgG Specific Kit Captia Herpes Simplex Virus (HSV) Group IgG Bartels ELISA Legionella Urinary Antigen Captia Rheumatoid Factor (RF) IgM Trinity Biotech Macra Lp(a) Captia MPO (p anca) Captia Jo-1 Captia ENA Combined Screen (6 Ag) Captia Histone Captia Mitochondria Captia Cytomegalovirus IgG Captia Borrelia burgdorferi IgG/IgM Trinity Biotech Glucose-6-Phosphate Dehydrogenase Captia Herpes Simplex Virus 2 (HSV 2) Type Specific IgG Captia Herpes Simplex Virus 2 (HSV 2) IgM Bartels Chlamydiae Isolation Medium. Captia HSV 1 IgG Bartels Viral/Chlamydia Freeze Media Bartels Chlam Trans Captia ANA Screen ImmuLisa ANA Screen ELISA Captia HSV 2 IgG MarDx Borrelia burgdorferi Lyme EIA IgM Specific Kit Bartels DEAE-dextran BioRad EBV EA-D IgG Captia EBV EA-D IgG Bartels Cul-trol BioRad Cytomegalovirus Total Antibody ELISA Test Kit Captia Cytomegalovirus Total Antibody ELISA Test Kit Trinity Biotech Captia Malaria ELISA Test Kit BioRad Malaria ELISA Test Kit Captia EBNA-1 IgM Captia Cytomegalovirus IgM Captia Varicella Zoster Virus IgG Bartels Flex Trans Medium Captia Herpes Simplex Virus (HSV) Combined IgM Captia Rubella IgM Captia Thyroglobulin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYR Helicobacter Pylori Microbiology Class 1 866.3110 1996-09-12
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 1992-07-16
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2007-12-26
LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus Microbiology Class 1 866.3380 1992-07-16
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2008-01-02
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2007-12-26
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2008-01-02
LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) Microbiology Class 1 866.3120 1997-10-01
LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Microbiology Class 2 866.3900 1997-10-01
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2007-12-26
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 1992-07-16
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-01-04
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2007-12-26
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2008-01-04
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-01-04
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2007-12-26
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2013-11-15
LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control Immunology Class 2 866.5100 2007-12-26
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2008-01-04
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2006-01-11
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2008-01-02
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 1992-07-16
MJH Legionella, Spp., Elisa Microbiology Class 2 866.3300 2008-01-02
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2007-12-26
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2007-12-26
JHO Electrophoretic Separation, Lipoproteins Clinical Chemistry Class 1 862.1475 2007-12-26
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2007-12-26
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2007-12-26
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2007-12-26
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2007-12-26
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2007-12-26
GQI Antiserum, Cf, Cytomegalovirus Microbiology Class 2 866.3175 2007-12-26
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2007-12-26
KHG Whole Blood Hemoglobin Determination Hematology Class 2 864.7500 2008-01-04
MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Microbiology Class 2 866.3305 2006-01-11
MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Microbiology Class 2 866.3305 2008-01-04
KIT Media And Components, Synthetic Cell And Tissue Culture Hematology Class 1 864.2220 2007-12-26
GQO Antisera, Cf, Herpesvirus Hominis 1,2 Microbiology Class 2 866.3305 2007-12-26
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2007-12-26
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2008-01-04
GQO Antisera, Cf, Herpesvirus Hominis 1,2 Microbiology Class 2 866.3305 2007-12-26
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2008-01-02
KIT Media And Components, Synthetic Cell And Tissue Culture Hematology Class 1 864.2220 2007-12-26
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2007-12-26
JSK Supplement, Culture Media Microbiology Class 1 866.2450 2007-12-26
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2014-09-17
OAX Plasmodium Spp. Detection Reagents Microbiology Class 2 866.3402 2014-09-18
LLM Test, Antigen, Nuclear, Epstein-Barr Virus Microbiology Class 1 866.3235 2007-12-26
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 1992-07-16
GQX Antiserum, Cf, Varicella-Zoster Microbiology Class 2 866.3900 1997-10-01
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2007-12-26
LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific Microbiology Class 2 866.3305 2008-01-04
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 1992-07-16
JNL Immunochemical, Thyroglobulin Autoantibody Immunology Class 2 866.5870 2007-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TRINITY BIOTECH, PLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3032069621 Trinity Biotech do Brasil Extrema Minas Gerais, BR
1931251 Trinity Biotech (Primus Corporation dba Trinity Biotech) KANSAS CITY, MO, US
9681576 TRINITY BIOTECH, PLC BRAY Wicklow, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K873780 Labsystems, Inc. MODIFICATION RUBELLA IGM EIA TEST KIT 1987-10-15
K954575 Abbott Laboratories AXSYM TOXO IGG ANTIBODY ASSAY 1996-08-16
K032162 Beckman Coulter, Inc. ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY 2003-08-08
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0081-2017 Siemens Healthcare Diagnostics, Inc. 2
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017 Siemens Healthcare Diagnostics, Inc. 2
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0023-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022 Sentinel CH SpA Via Robert Koch 2
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1318354. Last updated year: 2026. Please use registration number 1318354 when referencing this establishment in official correspondence.
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