This page includes the latest FDA filings for Tcoag Ireland L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008386529 | ||||||
| FEI Number | 3008386529 | ||||||
| Name | Donald Kraft | ||||||
| Owner & Operator | Tcoag Ireland Limited | ||||||
| Contact Address | IDA Business Park, Southern Cross Road Bray, Co. Wicklow N/A IE-WW Wicklow N/A IE | ||||||
| US Agent |
| ||||||
| Importing Logistics Registration |
| ||||||
| Registration Status | 1 | ||||||
| Initial Importer | N | ||||||
| Registration Expiration | 2020-04-25 | ||||||
| Registration Address | 5 Century Dr Parsippany Parsippany, NJ 07054 US | ||||||
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| TCOAG IRELAND LIMITED | TriniLIZE™ Stabilyte tubes | 2019-07-19 |
| TCOAG IRELAND LIMITED | DT Fluid | 2019-07-08 |
| TCOAG IRELAND LIMITED | DT Wash | 2019-07-08 |
| TCOAG IRELAND LIMITED | TriniCHECK Level 3 | 2019-07-08 |
| TCOAG IRELAND LIMITED | TriniCHECK Level 2 | 2019-07-08 |
| TCOAG IRELAND LIMITED | TriniCHECK Level 1 | 2019-07-08 |
| TCOAG IRELAND LIMITED | TriniCLOT Lupus Confirm | 2019-07-08 |
| TCOAG IRELAND LIMITED | TriniCLOT Lupus Screen | 2019-07-08 |
| TCOAG IRELAND LIMITED | Destiny System Fluid | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHECK™ Abnormal control | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Thrombin Time 4ml | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Thrombin Time 1ml | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHECK™ D-Dimer 3 | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHECK™ D-Dimer 2 | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHECK™ D-Dimer 1 | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCAL™ Fibrinogen | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCAL™ Reference Plasma | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHECK™ Lupus Positive Control | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Calcium Chloride 0.025M | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Imidazole Buffer | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor XII | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor XI | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor X | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor IX | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor VIII | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor VII | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor V | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Factor II | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Fibrinogen 6 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ aPTT HS 3 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ aPTT HS 10 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ PT HTF 6 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ PT HTF 20 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | Ristocetin (7.5 mg/vial) | 2018-07-06 |
| TCOAG IRELAND LIMITED | Adenosine Diphosphate (ADP) | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniLIZE™ PAI-1 Antigen | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniLIZE™ PAI-1 Activity | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniLIA™ D-Dimer | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHROM™ Factor VIII:C | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHROM™ Antithrombin Xa | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCHROM™ Antithrombin IIa | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Fibrinogen Kit | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ aPTT S 3 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ aPTT S 10 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ PT Excel 6 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ PT Excel S 6 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniCLOT™ PT Excel S 20 mL | 2018-07-06 |
| TCOAG IRELAND LIMITED | Lyophilized Platelets | 2018-07-06 |
| TCOAG IRELAND LIMITED | Ristocetin Cofactor Assay | 2018-07-06 |
| TCOAG IRELAND LIMITED | TriniLIA™ D-Dimer Saline | 2018-03-29 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Automated aPTT 3 mL | 2018-03-29 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Automated aPTT 6 mL | 2018-03-29 |
| TCOAG IRELAND LIMITED | Destiny MAX Analyzer | 2018-03-29 |
| TCOAG IRELAND LIMITED | Destiny Plus | 2018-03-29 |
| TCOAG IRELAND LIMITED | KC® 4 Delta | 2018-03-29 |
| TCOAG IRELAND LIMITED | KC® 1 Delta | 2018-03-29 |
| TCOAG IRELAND LIMITED | TriniVerical™ | 2018-03-29 |
| TCOAG IRELAND LIMITED | TriniCLOT™ Protein S | 2018-03-29 |
Donald Kraft [Tcoag Ireland Limited] | Destiny System Fluid | 2016-02-05 |
Donald Kraft [Tcoag Ireland Limited] | Control material (unlabelled) | 2012-05-25 |
Donald Kraft [Tcoag Ireland Limited] | STA - Desorb U (00975) | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | STA - Cleaner Solution (00973) | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | Destiny Prowash (DPW10/DPW20) | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | DT Wash (DTW) | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | DT Fluid (DTF) | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK Level 3 | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK Level 2 | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK Level 1 | 2012-02-29 |
Donald Kraft [Tcoag Ireland Limited] | MDA Verify III | 2010-11-15 |
Donald Kraft [Tcoag Ireland Limited] | MDA Verify II | 2010-11-15 |
Donald Kraft [Tcoag Ireland Limited] | MDA Verify 1 | 2010-11-15 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Automated aPTT 6ml | 2010-11-15 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Automated aPTT 3ml | 2010-11-15 |
Donald Kraft [Tcoag Ireland Limited] | TriniVeriCAL | 2010-11-10 |
Donald Kraft [Tcoag Ireland Limited] | MDA Imidazole Buffer | 2010-11-08 |
Donald Kraft [Tcoag Ireland Limited] | MDA D-Dimer | 2010-11-08 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor VIII | 2010-10-26 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT PT HTF 10 x 6ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT PT HTF 10 x 20ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHROM Antithrombin IIa | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Imidazole Buffer | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Fibrinogen Kit | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCAL Fibrinogen | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniLIZE PAI-1 Activity | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniLIZE tPA Activity | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniLIZE Stabilyte tubes | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK Lupus Positive control | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHROM Antithrombin Xa | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniLIZE PAI-1 Antigen | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHROM Antithrombin IIa | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHROM Factor VIII: C | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCAL Reference Plasma | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT aPTT S 5 x 3ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT aPTT S 5 x 10ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | Ristocetin Cofactor Assay | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | Platelets Lyophilized(Diluent) | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | ADP 0.2M | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK Abnormal control | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | Ristocetin | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor II | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Thrombin 10 x 4ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Thrombin 10 x 1ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Calcium Chloride (0.025M) | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor XI | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor VIII | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor VII | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor XII | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor V | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor IX | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Factor X | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT PT Excel S 5 x 20ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT PT Excel S 10 x 6ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT aPTT HS 10 x 3ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT aPTT HS 10 x 10ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCAL Reference Plasma | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT PT excel 10 x 6ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT PT Excel 5 x 20ml | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | MDA Fibriquik | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK D-Dimer 3 | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | D-Dimer Control Level 3 | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK D-Dimer 2 | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | D-Dimer Control Level 2 | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCHECK D-Dimer 1 | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | D-Dimer Control Level 1 | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniLIA D-Dimer | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | Auto D-Dimer Kit | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | Auto D-Dimer Calibrator | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Lupus Confirm | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | Accuclot DRVVT Confirm | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | TriniCLOT Lupus Screen | 2010-05-28 |
Donald Kraft [Tcoag Ireland Limited] | Accuclot DRVVT Screen | 2010-05-28 |