TriniCHECK Level 1

GUDID 15391521420630

Multiple coagulation factor IVD, control

Primary Device ID	15391521420630
NIH Device Record Key	7bc2de39-fe52-49bd-b0be-9487b900cedd
Commercial Distribution Status	In Commercial Distribution
Brand Name	TriniCHECK Level 1
Version Model Number	T4111
Company DUNS	985039126
Company Name	TCOAG IRELAND LIMITED
Device Count	10
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature

Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	05391521420633 [Unit of Use]
GS1	15391521420630 [Primary]

OHQ	Multi-Analyte Controls Unassayed

Steralize Prior To Use	false
Device Is Sterile	false