Data / Medical devices / United States / Trinity Biotech USA
Trinity Biotech USA: FDA-registered device maker in Jamestown, NY, United States, 58 510(k) clearances
Trinity Biotech USA is registered with the FDA (registration 1318354) in Jamestown, NY, United States. It lists 41 device types. The FDA files 58 510(k) clearances under its listings, the newest dated May 22, 2014. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1318354
- Address
- 2823 Girts Rd, Jamestown, NY, United States, 14701
- Owner or operator
- TRINITY BIOTECH, PLC (9025161)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- July 16, 1992
- Registered through
- 2026
- Brand names listed
- Bartels Chlam Trans, Bartels Chlamydiae Isolation Medium., Bartels Cul-trol, Bartels DEAE-dextran, Bartels ELISA Legionella Urinary Antigen, Bartels Flex Trans Medium, Bartels Tissue Culture Refeed Medium, Bartels Viral/Chlamydia Freeze Media and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2014 | K140455 | CAPTIA MEASLES IGM | PCL | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| July 13, 2004 | K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | MYF | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| July 13, 2004 | K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | MXJ | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| November 26, 2003 | K033083 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | LSR | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| November 26, 2003 | K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | LJC | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| November 26, 2003 | K033067 | PYLORI IGG | LYR | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| November 26, 2003 | K033064 | MYCOPLASMA IGG | LON | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| November 26, 2003 | K033059 | HERPES GROUP IGG | LGC | Substantially Equivalent | Trinity Biotech, Inc. | accessdata.fda.gov |
| November 26, 2003 | K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | MJH | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| January 24, 2002 | K014233 | CAPTIAM SYPHILIS-G ASSAY | LIP | Substantially Equivalent | Trinity Biotech, Plc | accessdata.fda.gov |
| January 12, 2000 | K993839 | ENA PROFILE ELISA TEST SYSTEM | LLL | Substantially Equivalent | Trinity Biotech USA | accessdata.fda.gov |
| December 21, 1999 | K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | MJH | Substantially Equivalent | Intracel Corp. | accessdata.fda.gov |
| July 22, 1998 | K980912 | VCA IGG ELISA TEST SYSTEM | LSE | Substantially Equivalent | Clark Laboratories, Inc. | accessdata.fda.gov |
| July 22, 1998 | K980596 | VCA IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | Clark Laboratories, Inc. | accessdata.fda.gov |
| May 1, 1998 | K980598 | EBNA-1 IGM ELISA TEST SYSTEM | LLM | Substantially Equivalent | Clark Laboratories, Inc. | accessdata.fda.gov |
| April 15, 1998 | K971157 | MACRALP(A) ENZYME IMMUNOASSAY KIT | JHO | Substantially Equivalent | Strategic Diagnostics, Inc. | accessdata.fda.gov |
| March 26, 1998 | K973123 | EA-D IGG ELISA TEST SYSTEM | LSE | Substantially Equivalent | Clark Laboratories, Inc. | accessdata.fda.gov |
| August 19, 1996 | K961765 | MPO ELISA TEST SYSTEM | MOB | Substantially Equivalent | Immunoprobe, Inc. | accessdata.fda.gov |
| August 19, 1996 | K961764 | PR-3 ELISA TEST SYSTEM | MOB | Substantially Equivalent | Immunoprobe, Inc. | accessdata.fda.gov |
| April 29, 1996 | K951549 | EBNA IGG EIA TEST SYSTEM | LLM | Substantially Equivalent | Immunoprobe, Inc. | accessdata.fda.gov |
| December 15, 1995 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | LKJ | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| August 15, 1994 | K935987 | FLEXTRANS | JSM | Substantially Equivalent | Baxter Diagnostics, Inc. | accessdata.fda.gov |
| June 2, 1994 | K935413 | ENA EIA TEST KIT | LLL | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 11, 1994 | K941358 | THYROGLOBULIN EIA TEST KIT | JNL | Substantially Equivalent | Immunoprobe, Inc. | accessdata.fda.gov |
| May 5, 1994 | K935419 | LA EIA TEST KIT | LLL | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 5, 1994 | K935418 | SCL-70 EIA TEST KIT | LLL | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 5, 1994 | K935417 | JO-1 EIA TEST KIT | LLL | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 3, 1994 | K940251 | MITOCHONDRIA EIA TEST KIT | DBM | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 2, 1994 | K940253 | HISTONE EIA TEST KIT | LJM | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 2, 1994 | K935416 | RO EIA TEST KIT | LJM | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 2, 1994 | K935415 | RNP EIA TEST KIT | LJM | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| May 2, 1994 | K935414 | SM EIA TEST KIT | LJM | Substantially Equivalent | David A. Fuccillo, Ph.D. | accessdata.fda.gov |
| June 7, 1993 | K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR | JIS | Substantially Equivalent | Analytical Control Systems, Inc. | accessdata.fda.gov |
| December 23, 1992 | K923537 | ENCORE DS-DNA | LRM | Substantially Equivalent | Clark Laboratories, Inc. | accessdata.fda.gov |
| September 25, 1992 | K924056 | ENCORE RHEUMATOID FACTOR EIA | DHR | Substantially Equivalent | Clark Laboratories, Inc. | accessdata.fda.gov |
| August 27, 1992 | K921573 | RUBELLA IGM | LFX | Substantially Equivalent | Clark Laboratories, Inc. | accessdata.fda.gov |
| July 27, 1992 | K921011 | PHARMACIA CMV IGM ELISA | LFZ | Substantially Equivalent | Pharmacia Diagnostics, Inc. | accessdata.fda.gov |
| July 8, 1992 | K920702 | TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO | LGD | Substantially Equivalent | Pharmacia Diagnostics, Inc. | accessdata.fda.gov |
| January 27, 1992 | K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | LFY | Substantially Equivalent | Pharmacia Diagnostics, Inc. | accessdata.fda.gov |
| July 26, 1990 | K897006 | PHARMACIA MUMPS IGG ELISA | LJY | Substantially Equivalent | Pharmacia Eni Diagnostics, Inc. | accessdata.fda.gov |
| August 21, 1989 | K894293 | MARDX LYME DISEASE EIA (IGM) TEST SYSTEM | LSR | Substantially Equivalent | Mardx Diagnostics, Inc. | accessdata.fda.gov |
| August 21, 1989 | K894224 | MARDX LYME DISEASE EIA (IGG) TEST SYSTEM | LSR | Substantially Equivalent | Mardx Diagnostics, Inc. | accessdata.fda.gov |
| August 15, 1989 | K892206 | MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM | LSR | Substantially Equivalent | Mardx Diagnostics, Inc. | accessdata.fda.gov |
| April 28, 1989 | K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | GNP | Substantially Equivalent | Electro-Nucleonics, Inc. | accessdata.fda.gov |
| March 10, 1989 | K883427 | VIRGO(R) VZV-IGG ELISA | GQX | Substantially Equivalent | Electro-Nucleonics, Inc. | accessdata.fda.gov |
| March 10, 1989 | K883282 | VIRGO HSV-1 IGG ELISA | GQO | Substantially Equivalent | Electro-Nucleonics, Inc. | accessdata.fda.gov |
| March 10, 1989 | K883281 | VIRGO HSV-2 IGG ELISA | GQO | Substantially Equivalent | Electro-Nucleonics, Inc. | accessdata.fda.gov |
| February 8, 1989 | K883102 | VIRGO (R) CMV-IGG ELISA | GQI | Substantially Equivalent | Electro-Nucleonics, Inc. | accessdata.fda.gov |
| February 24, 1988 | K873925 | VIRGO(TM) MEASLES IGG ELISA | LJB | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. | accessdata.fda.gov |
| September 9, 1987 | K873088 | VIRGO(TM) RUBELLA IGG ELISA | LFX | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. | accessdata.fda.gov |
| July 30, 1987 | K871905 | TOXOPLASMA GONDII IGG ELISA | LGD | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. | accessdata.fda.gov |
| February 19, 1986 | K860453 | ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 | JJX | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| April 20, 1984 | K834116 | DEAE-DEXTRAN IN PBS | KIT | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. | accessdata.fda.gov |
| March 23, 1984 | K834115 | CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT | JSK | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. | accessdata.fda.gov |
| March 23, 1984 | K834113 | TISSUE CULTURE REFEEDING MEDIUM | KIT | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. | accessdata.fda.gov |
| February 13, 1984 | K834125 | CHLAMYDIAL TRANSPORT MEDIUM | JSM | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. | accessdata.fda.gov |
| February 13, 1984 | K834122 | CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX | KIT | Substantially Equivalent | Bartels Immunodiagnostic Supplies, Inc. | accessdata.fda.gov |
| November 12, 1980 | K802568 | HEMOGLOBIN CONTROL | KHG | Substantially Equivalent | Marilyn L. Amick | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 22, 2025 | 97117 | Class II | Ongoing | Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease. | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. | accessdata.fda.gov |
| October 11, 2021 | 89088 | Class II | Terminated | Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Prod | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay | accessdata.fda.gov |
| March 17, 2021 | 87637 | Class II | Terminated | Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection. | Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting | accessdata.fda.gov |
| November 1, 2018 | 81488 | Class II | Terminated | ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | lack of 510K | accessdata.fda.gov |
| July 11, 2016 | 74932 | Class III | Terminated | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD | The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range). | accessdata.fda.gov |
| November 17, 2014 | 69827 | Class III | Terminated | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodie | Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months. | accessdata.fda.gov |
| August 27, 2013 | 66916 | Class II | Terminated | Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide | Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. | accessdata.fda.gov |
| May 29, 2012 | 62440 | Class III | Terminated | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human se | The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range. | accessdata.fda.gov |
| October 27, 2004 | 30354 | Not yet classified | Terminated | AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, | Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value. | accessdata.fda.gov |
Compare with other makers
- All makers of Enzyme Linked Immunoabsorbent Assay, Rubella
- All makers of Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- All makers of Extractable Antinuclear Antibody, Antigen And Control
- All makers of Test, Antigen, Nuclear, Epstein-Barr Virus
- All makers of Plasmodium Spp. Detection Reagents
- All makers of Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Updated August 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.