Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008386529

FEI Number

3008386529

Entity Name

TCOAG IRELAND LIMITED

City/State/Country

BRAY Wicklow, IE

Establishment Address

IDA BUSINESS PARK, SOUTHERN CROSS ROAD, BRAY Wicklow --, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tcoag Ireland Limited (Owner Number: 10032571)

Owner / Operator Contact Address

IDA Business Park, Southern Cross Road, Bray, Co. Wicklow, Bray, IE-WW A98X383, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K896052

PMA Number

N/A

All Registered Proprietary Names

TriniCLOT Factor IX TriniCLOT PT Excel S 10 x 6ml TriniCLOT PT Excel S 5 x 20ml TriniCLOT aPTT HS 10 x 10ml TriniCLOT aPTT HS 10 x 3ml TriniCLOT Factor XI TriniCLOT Factor V DT Wash (DTW) DT Fluid (DTF) STA - Cleaner Solution (00973) STA - Desorb U (00975) TriniCAL Fibrinogen TriniCLOT Imidazole Buffer TriniCLOT Fibrinogen Kit TriniCLOT Automated aPTT 3ml TriniCLOT Automated aPTT 6ml TriniCHECK D-Dimer 3 D-Dimer Control Level 3 TriniCHECK Abnormal control TriniCHECK Level 1 TriniCHECK Level 2 TriniCHECK Level 3 TriniCHROM Factor VIII: C TriniCLOT aPTT S 5 x 10ml TriniCLOT aPTT S 5 x 3ml TriniCLOT Factor VII TriniCLOT Factor VIII D-Dimer Control Level 2 TriniCHECK D-Dimer 2 TriniCHROM Antithrombin IIa TriniCAL Reference Plasma TriniCLOT Factor VIII TriniCLOT Factor II Accuclot DRVVT Confirm TriniCLOT Lupus Confirm Ristocetin TriniCLOT Factor XII TriniCLOT Factor X TriniCAL Reference Plasma TriniCLOT Lupus Screen Accuclot DRVVT Screen TriniCLOT Calcium Chloride (025M) TriniCLOT Thrombin 10 x 4ml TriniCLOT Thrombin 10 x 1ml

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-05-28
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2010-05-28
GIT	Reagent & Control, Partial Thromboplastin Time	Hematology	Class 2	864.7925	2010-05-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-05-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-05-28
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2012-02-29
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2010-05-28
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2010-11-15
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2010-05-28
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2010-05-28
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2012-02-29
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2010-05-28
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2010-05-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-05-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2010-05-28
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2010-05-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2010-05-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-10-26
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-05-28
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2010-05-28
GHR	Reagent, Platelet Aggregation	Hematology	Class 2	864.5700	2010-05-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-05-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2010-05-28
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2010-05-28
GIR	Reagent, Russel Viper Venom	Hematology	Class 1	864.8950	2010-05-28
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2010-05-28
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2010-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

Donald Kraft Business: Diagnostica Stago, Inc Email: donald.kraft@us.stago.com Phone: (973) 6311200

Related Public Records

Same Entity

Tcoag Ireland Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934605	American Bioproducts Co.	STAGO FACTOR V-DEFICIENT PLASMA	1994-03-01
K180486	Instrumentation Laboratory CO	HemosIL Factor XII Deficient Plasma	2018-03-22
K043459	Instrumentation Laboratory CO	HEMOSIL FACTOR XII DEFICIENT PLASMA	2005-02-09
K020679	Hemosense, Inc.	INRATIO	2002-05-06
K070005	Instrumentation Laboratory CO	HEMOSIL RECOMBIPLASTIN 2G	2007-08-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0077-2019	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Z-0832-2015	Instrumentation Laboratory Co.	2	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Z-0895-2018	Instrumentation Laboratory Co.	2	Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Z-1246-06	Instrumentation Laboratory Co.	2	HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.
Z-1247-06	Instrumentation Laboratory Co.	2	Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE.

Similar Registrations

Registration Number	Establishment Name	Location
8043599	Precision BioLogic Inc.	Dartmouth Nova Scotia, CA
9710666	Diagnostica Stago - Taverny	Taverny Val-d'Oise, FR
1530434	DIAPHARMA GROUP, INC.	WEST CHESTER, OH, US
9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008386529. Last updated year: 2026. Please use registration number 3008386529 when referencing this establishment in official correspondence.