TriniCHROM™ Antithrombin Xa

GUDID 05391521420541

TCOAG IRELAND LIMITED

Antithrombin III (ATIII) IVD, kit, chromogenic
Primary Device ID05391521420541
NIH Device Record Key2552a8d0-2f0f-4d10-955d-9c0b572095cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriniCHROM™ Antithrombin Xa
Version Model NumberT2603
Company DUNS985039126
Company NameTCOAG IRELAND LIMITED
Device Count1
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105391521420541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JBQAntithrombin Iii Quantitation

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

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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 [TriniCHROM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRINICHROM
TRINICHROM
77353774 3681954 Live/Registered
TCOAG IRELAND LIMITED
2007-12-17

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