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Sign in to claim this brandWhat TCOAG IRELAND LIMITED makes
The company manufactures in vitro diagnostic (IVD) kits and reagents for coagulation testing, including activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen assays, and D-dimer controls. Additional products include calibrators, controls, and buffered wash solutions for multiple coagulation factors, as well as specific reagents like ristocetin and lupus anticoagulant markers. The portfolio also covers clotting assays and pre-mixed fluid systems for laboratory use.
These devices are classified under FDA’s Class I and Class II regulatory categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for in vitro diagnostics.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does TCOAG Ireland Limited manufacture?
TCOAG Ireland Limited specializes in in vitro diagnostic (IVD) devices, specifically coagulation testing kits and reagents. Their portfolio includes activated partial thromboplastin time (APTT) and prothrombin time (PT) kits, fibrinogen assays, D-dimer controls, calibrators, and buffered wash solutions for coagulation factors. They also produce specialized reagents like ristocetin and lupus anticoagulant markers, as well as pre-mixed fluid systems for laboratory use.
Where is TCOAG Ireland Limited based, and how does this affect their devices?
TCOAG Ireland Limited is based in the United States, where they develop and manufacture their IVD devices. Since they operate within the U.S., their products must comply with applicable U.S. regulatory requirements for in vitro diagnostics, including classification under FDA’s regulatory framework.
Which regulatory registries list TCOAG Ireland Limited’s devices?
TCOAG Ireland Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for coagulation testing kits, calibrators, controls, and other related products under their portfolio.
How are TCOAG Ireland Limited’s devices classified under U.S. regulations?
TCOAG Ireland Limited’s devices fall under FDA’s Class I and Class II regulatory categories. Class I generally includes low-risk devices like some IVD reagents, while Class II involves moderate-risk devices requiring special controls to ensure safety and effectiveness, such as certain coagulation testing kits and calibrators.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 985039126
Catalogue (47)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ristocetin (7.5 mg/vial) | 50705 | FDA UDI | Class II | Active |
| TriniCLOT™ Protein S | T1602 | FDA UDI | Class II | Unknown |
| TriniCHECK™ D-Dimer 1 | T4303 | FDA UDI | Class II | Active |
| Destiny System Fluid | DSF | FDA UDI | Class II | Active |
| TriniCHECK™ D-Dimer 2 | T4304 | FDA UDI | Class II | Active |
| TriniCHECK Level 2 | T4112 | FDA UDI | Class I | Active |
| TriniCHECK™ Abnormal control | T4104 | FDA UDI | Class II | Active |
| TriniCLOT™ PT HTF 20 mL | T1101 | FDA UDI | Class II | Active |
| Lyophilized Platelets | 50710 | FDA UDI | Class II | Unknown |
| TriniCLOT™ Factor XII | T1512 | FDA UDI | Class II | Active |
| TriniCLOT™ PT Excel 6 mL | T1106 | FDA UDI | Class II | Active |
| TriniCLOT™ Fibrinogen 6 mL | T1302 | FDA UDI | Class II | Active |
| TriniCLOT™ Thrombin Time 1ml | T1411 | FDA UDI | Class II | Active |
| TriniCLOT™ Thrombin Time 4ml | T1414 | FDA UDI | Class II | Active |
| TriniCHECK™ Lupus Positive Control | T4203 | FDA UDI | Class II | Active |
| TriniCLOT™ Automated aPTT 3 mL | T1206 | FDA UDI | Class II | Active |
| TriniCLOT™ Calcium Chloride 0.025M | T1902 | FDA UDI | Class II | Active |
| TriniCLOT™ Factor X | T1510 | FDA UDI | Class II | Active |
| TriniCLOT™ aPTT HS 3 mL | T1204 | FDA UDI | Class II | Active |
| TriniCLOT™ Factor XI | T1511 | FDA UDI | Class II | Active |
| TriniCAL™ Reference Plasma | T5102 | FDA UDI | Class II | Active |
| TriniCLOT™ Factor VII | T1507 | FDA UDI | Class II | Active |
| Ristocetin Cofactor Assay | 50750 | FDA UDI | Class II | Unknown |
| TriniCAL™ Fibrinogen | T5104 | FDA UDI | Class II | Active |
| TriniCLOT™ Imidazole Buffer | T1901 | FDA UDI | Class II | Active |
| TriniCLOT™ Factor II | T1502 | FDA UDI | Class II | Active |
| TriniCLOT™ Automated aPTT 6 mL | T1205 | FDA UDI | Class II | Active |
| TriniCHECK™ D-Dimer 3 | T4305 | FDA UDI | Class II | Active |
| TriniCLOT™ aPTT S 3 mL | T1202 | FDA UDI | Class II | Active |
| TriniLIZE™ PAI-1 Activity | T6004 | FDA UDI | Class II | Active |
| DT Wash | DTW | FDA UDI | Class I | Active |
| TriniCLOT™ Factor V | T1505 | FDA UDI | Class II | Active |
| TriniCLOT Lupus Confirm | T1605 | FDA UDI | Class I | Active |
| TriniCLOT™ Factor IX | T1509 | FDA UDI | Class II | Active |
| TriniCHROM™ Antithrombin Xa | T2603 | FDA UDI | Class II | Active |
| TriniLIZE™ Stabilyte tubes | T6006 | FDA UDI | Class I | Unknown |
| TriniCLOT™ PT HTF 6 mL | T1102 | FDA UDI | Class II | Active |
| TriniCLOT™ aPTT HS 10 mL | T1203 | FDA UDI | Class II | Active |
| TriniCLOT Lupus Screen | T1604 | FDA UDI | Class I | Active |
| TriniCHECK Level 1 | T4111 | FDA UDI | Class I | Active |
| TriniCLOT™ Factor VIII | T1508 | FDA UDI | Class II | Active |
| TriniLIZE™ PAI-1 Antigen | T6003 | FDA UDI | Class II | Active |
| TriniCHECK Level 3 | T4113 | FDA UDI | Class I | Active |
| TriniVerical™ | T5103 | FDA UDI | Class I | Active |
| DT Fluid | DTF | FDA UDI | Class I | Active |
| TriniLIA™ D-Dimer Saline | T3000 | FDA UDI | Class II | Unknown |
| Adenosine Diphosphate (ADP) | 50704 | FDA UDI | Class II | Unknown |
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