TriniCHROM™ Antithrombin IIa

GUDID 05391521420534

TCOAG IRELAND LIMITED

Antithrombin III (ATIII) IVD, kit, chromogenic
Primary Device ID05391521420534
NIH Device Record Key7485e036-7216-4f61-a07e-2ec95a7c2602
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriniCHROM™ Antithrombin IIa
Version Model NumberT2602
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
GS105391521420534 [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

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 [TriniCHROM]

Mark Image

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.