directCHECK Whole Blood Controls DCJ-005

GUDID 10711234540046

Coagulation analyser IVD, point-of-care, line-powered

Primary Device ID	10711234540046
NIH Device Record Key	d514429f-6729-41ae-a744-b4798cab6871
Commercial Distribution Status	In Commercial Distribution
Brand Name	directCHECK Whole Blood Controls
Version Model Number	DCJ-005
Catalog Number	DCJ-005
Company DUNS	079299318
Company Name	ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	10711234540046 [Primary]

GGN	Plasma, Coagulation Control

Steralize Prior To Use	false
Device Is Sterile	false

10711234540046	Protective Sleeves
10711234170243	directCHECK ACT-LR - Normal 15/box
10711234170236	directCHECK PT - Normal 15/box
10711234170229	directCHECK ACT+ Normal 15/box
10711234170175	directCHECK Citrate APTT - Abnormal 15/box
10711234107089	directCHECK ACT-LR Abnormal 15/box
10711234107072	directCHECK Citrate PT - Normal 15/box
10711234107065	directCHECK Citrate PT - Abnormal 15/box
10711234107058	directCHECK ACT+ Abnormal 15/box
10711234107041	directCHECK PT - Abnormal 15/box
10711234107034	directCHECK APTT - Abnormal 15/box
10711234107027	directCHECK APTT- Normal 15/box