DRUGS OF ABUSE CAL

GUDID B80010029000011

Multiple therapeutic drugs/drugs of abuse IVD, control

Primary Device ID	B80010029000011
NIH Device Record Key	39e000dd-95c6-4cab-a5c1-5453d44c9a17
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRUGS OF ABUSE CAL
Version Model Number	DA+ CAL M LB
Company DUNS	092519016
Company Name	UTAK LABORATORIES, INC.
Device Count	1
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	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
HIBCC	B80010029000010 [Primary]
HIBCC	B80010029000011 [Package] Contains: B80010029000010 Package: Box [4 Units] In Commercial Distribution
HIBCC	B80010029000012 [Package] Contains: B80010029000010 Package: Box [5 Units] In Commercial Distribution
HIBCC	B80010029000013 [Package] Contains: B80010029000010 Package: Box [10 Units] In Commercial Distribution
HIBCC	B80010029000016 [Package] Contains: B80010029000010 Package: Box [25 Units] In Commercial Distribution
HIBCC	B80010029000017 [Package] Contains: B80010029000010 Package: Box [50 Units] In Commercial Distribution
HIBCC	B80010029000018 [Package] Contains: B80010029000010 Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false