IBSchek IVD-1-Chek

GUDID 00856820008005

Specimen mailer kit

Primary Device ID	00856820008005
NIH Device Record Key	af66be35-2b5e-4682-9b6a-592012fb7149
Commercial Distribution Status	In Commercial Distribution
Brand Name	IBSchek
Version Model Number	IVD-1-Chek
Catalog Number	IVD-1-Chek
Company DUNS	080680537
Company Name	COMMONWEALTH DIAGNOSTICS INTERNATIONAL, INC.
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	true
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
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	00856820008005 [Primary]

PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)

Steralize Prior To Use	false
Device Is Sterile	false

Mark Image Registration \| Serial	Company Trademark Application Date
IBSCHEK 87834115 5557514 Live/Registered	Commonwealth Diagnostics International Inc. 2018-03-14
IBSCHEK 86578858 not registered Dead/Abandoned	COMMONWEALTH LABORATORIES, LLC 2015-03-27