TCOAG IRELAND LIMITED

Address:IDA BUSINESS PARK,BRAY Wicklow,IE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Activated Partial Thromboplastin (GFO) (2) Reagent & Control, Partial Thromboplastin Time (GIT) (2) Reagent, Platelet Aggregation (GHR) (2) Test, Time, Prothrombin (GJS) (2) Plasma, Coagulation Factor Deficient (GJT) (1) System, Fibrinogen Determination (KQJ) (1)

Premarket Exempt

No Yes

Clear

Adenosine Diphosphate (ADP) - 15391521420067 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : GHR

Prescription Use : Yes

Device Count : 3

Ristocetin (7.5 mg/vial) - 15391521420081 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : GHR

Prescription Use : Yes

Device Count : 10

TriniCLOT™ PT HTF 20 mL - 15391521420234 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 10

TriniCLOT™ PT HTF 6 mL - 15391521420241 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 10

TriniCLOT™ aPTT HS 10 mL - 15391521420319 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : GIT

Prescription Use : Yes

Device Count : 10

TriniCLOT™ aPTT HS 3 mL - 15391521420326 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : GIT

Prescription Use : Yes

Device Count : 10

TriniCLOT™ Automated aPTT 6 mL - 15391521420333 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : Yes

Product Code : GFO

Prescription Use : Yes

Device Count : 10

TriniCLOT™ Automated aPTT 3 mL - 15391521420340 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : Yes

Product Code : GFO

Prescription Use : Yes

Device Count : 10

TriniCLOT™ Fibrinogen 6 mL - 15391521420364 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : KQJ

Prescription Use : Yes

Device Count : 10

TriniCLOT™ Factor II - 15391521420371 Catalog Number :

Device Class :

Duns Number: 985039126

Premarket Exempt : No

Product Code : GJT

Prescription Use : Yes

Device Count : 10

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