FDA Registration
Active
🇺🇸 United States
Trinity Biotech USA
Reg #: 1318354
·
FEI: 1318354
·
Expires 2026
Products
41
Proprietary Names
84
Establishment Types
3
Classifications
41
Registration Details
- Registration Name
- Trinity Biotech USA
- Registration Number
- 1318354
- FEI Number
- 1318354
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2823 Girts Rd
- City
- Jamestown
- State
- NY
- ZIP
- 14701
- Country
- US
Regulatory Submissions
- 510(k) Number
- K033067
Owner / Operator
- Firm Name
- TRINITY BIOTECH, PLC
- Operator Number
- 9025161
- Address
- 2823 Girts Rd
- City
- Jamestown
- State
- NY
- Postal Code
- 14701
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 1996-09-12 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 1992-07-16 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2007-12-26 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 1992-07-16 |
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2008-01-02 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2007-12-26 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2008-01-02 |
| Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | LJC | Class 1 | Microbiology | No | 1997-10-01 |
| Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | LFY | Class 2 | Microbiology | No | 1997-10-01 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2007-12-26 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 1992-07-16 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2008-01-04 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2008-01-04 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2008-01-04 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2007-12-26 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2007-12-26 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 1992-07-16 |
| Legionella, Spp., Elisa | MJH | Class 2 | Microbiology | No | 2008-01-02 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2007-12-26 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2007-12-26 |
| Electrophoretic Separation, Lipoproteins | JHO | Class 1 | Clinical Chemistry | No | 2007-12-26 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2007-12-26 |
| Antiserum, Cf, Cytomegalovirus | GQI | Class 2 | Microbiology | No | 2007-12-26 |
| Whole Blood Hemoglobin Determination | KHG | Class 2 | Hematology | No | 2008-01-04 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | MYF | Class 2 | Microbiology | No | 2006-01-11 |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | Class 1 | Hematology | No | 2007-12-26 |
| Antisera, Cf, Herpesvirus Hominis 1,2 | GQO | Class 2 | Microbiology | No | 2007-12-26 |
| Culture Media, Non-Propagating Transport | JSM | Class 1 | Microbiology | No | 2007-12-26 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2008-01-04 |
| Supplement, Culture Media | JSK | Class 1 | Microbiology | No | 2007-12-26 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2014-09-17 |
| Plasmodium Spp. Detection Reagents | OAX | Class 2 | Microbiology | No | 2014-09-18 |
| Test, Antigen, Nuclear, Epstein-Barr Virus | LLM | Class 1 | Microbiology | No | 2007-12-26 |
| Antiserum, Cf, Varicella-Zoster | GQX | Class 2 | Microbiology | No | 1997-10-01 |
| Immunochemical, Thyroglobulin Autoantibody | JNL | Class 2 | Immunology | No | 2007-12-26 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2008-01-04 |
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | Class 2 | Microbiology | No | 1997-10-01 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 1992-07-16 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | PCL | Class 1 | Microbiology | No | 2014-09-17 |
| Antiserum, Cf, Epstein-Barr Virus | GNP | Class 1 | Microbiology | No | 2007-12-26 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2021-04-21 |
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
Captia EBNA-1 IgG
BioRad EBNA-1 IgG
Captia Mycoplasma IgM
Captia Mycoplasma IgG
Captia Measles IgG
Captia Mumps IgM
Captia Sm/RNP
Captia Measles IgM ELISA Test Kit
Captia Toxoplasma gondii IgG
Captia SS-A (Ro)
Captia Legionella pneumophila IgG/IgM
Captia EBV VCA (P-18) IgG
Captia EBV VCA IgG
BioRad EBV VCA IgG
Bartels Tissue Culture Refeed Medium
Captia SARS-CoV-2 IgG
Captia ENA Profile
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only