Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681576

FEI Number

3002546385

Entity Name

TRINITY BIOTECH, PLC

City/State/Country

BRAY Wicklow, IE

Establishment Address

IDA BUSINESS PARK, BRAY Wicklow --, IE

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bartels Flex Trans Medium Trinity Biotech Trinity Biotech IMMUCOR GAMMA Human Platelet Concebtrate IMMUCOR GAMMA Freeze Dried Papain Trinity Biotech Trinity Biotech Trinity Biotech Trinity Biotech IMMUCOR GAMMA W.A.R.M. (Warm Autoantibody Removal Medium) Trinity Biotech

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2007-12-26
KQN	Radioassay, Angiotensin Converting Enzyme	Clinical Chemistry	Class 2	862.1090	2007-12-31
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-28
MYP	Test, Platelet Antibody	Unknown	Class 2	N/A	2013-12-06
KSK	Solution, Stabilized Enzyme	Hematology	Class 2	864.9400	2013-12-06
KWW	Radioimmunoassay, Cholyglycine, Bile Acids	Clinical Chemistry	Class 2	862.1177	2007-12-28
JBF	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening	Hematology	Class 2	864.7360	2007-12-28
JBG	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot	Hematology	Class 2	864.7360	2007-12-28
LPW	System, Test, Oxalate	Clinical Chemistry	Class 1	862.1542	2007-12-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-28
KSK	Solution, Stabilized Enzyme	Hematology	Class 2	864.9400	2013-12-09
JBG	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot	Hematology	Class 2	864.7360	2007-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

Kaitlyn Eastman Business: Trinity Biotech Email: kaitlyn.eastman@trinitybiotech.com Phone: (716) 4837423

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
1318354	Trinity Biotech USA	Jamestown, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681576. Last updated year: 2026. Please use registration number 9681576 when referencing this establishment in official correspondence.