ABX PENTRA CK CONTROL

GUDID 03610230005545

Creatine kinase (CK) multiple isoenzyme IVD, control

Primary Device ID	03610230005545
NIH Device Record Key	cda26835-4bff-40a3-876b-f1fda62042c0
Commercial Distribution Discontinuation	2017-05-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	ABX PENTRA CK CONTROL
Version Model Number	1220001786
Company DUNS	273647420
Company Name	HORIBA ABX SAS
Device Count	1
DM Exempt	false
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	true
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	03610230005545 [Primary]

JJY	Multi-Analyte Controls, All Kinds (Assayed)

Steralize Prior To Use	false
Device Is Sterile	false