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

Test, Qualitative And Quantitative Factor Deficiency (GGP) (3) Test, Time, Prothrombin (GJS) (3) Activated Partial Thromboplastin (GFO) (2) Antithrombin Iii Quantitation (JBQ) (1) System, Fibrinogen Determination (KQJ) (1)

Premarket Exempt

No Yes

Clear

Ristocetin Cofactor Assay - 05391521420077 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

Lyophilized Platelets - 05391521420091 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

TriniCLOT™ PT Excel S 20 mL - 05391521420251 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

TriniCLOT™ PT Excel S 6 mL - 05391521420268 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

TriniCLOT™ PT Excel 6 mL - 05391521420282 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

TriniCLOT™ aPTT S 10 mL - 05391521420299 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GFO

Prescription Use : Yes

Device Count : 1

TriniCLOT™ aPTT S 3 mL - 05391521420305 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GFO

Prescription Use : Yes

Device Count : 1

TriniCLOT™ Fibrinogen Kit - 05391521420350 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : KQJ

Prescription Use : Yes

Device Count : 1

TriniCLOT™ Protein S - 05391521420466 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : GGP

Prescription Use : Yes

Device Count : 1

TriniCHROM™ Antithrombin IIa - 05391521420534 Catalog Number :

Device Class : 2

Duns Number: 985039126

Premarket Exempt : No

Product Code : JBQ

Prescription Use : Yes

Device Count : 1

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