TriniCLOT™ Thrombin Time 1ml

GUDID 15391521420814

TCOAG IRELAND LIMITED

Fibrinogen assay (factor I) IVD, kit, clotting
Primary Device ID15391521420814
NIH Device Record Key8706beb0-e0f5-4f7d-bb13-4473547521d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriniCLOT™ Thrombin Time 1ml
Version Model NumberT1411
Company DUNS985039126
Company NameTCOAG IRELAND LIMITED
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391521420817 [Unit of Use]
GS115391521420814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQJSystem, Fibrinogen Determination

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

Devices Manufactured by TCOAG IRELAND LIMITED

15391521421286 - TriniLIZE™ Stabilyte tubes 2019-07-19
15391521420470 - TriniCLOT Lupus Screen2019-07-08
15391521420487 - TriniCLOT Lupus Confirm2019-07-08
15391521420630 - TriniCHECK Level 12019-07-08
15391521420647 - TriniCHECK Level 22019-07-08
15391521420654 - TriniCHECK Level 32019-07-08
15391521421309 - DT Wash2019-07-08
15391521421729 - DT Fluid2019-07-08

Trademark Results [TriniCLOT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRINICLOT
TRINICLOT
77353758 3681953 Live/Registered
TCOAG IRELAND LIMITED
2007-12-17

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