DRUGS OF ABUSE QC

GUDID B80010029000020

Multiple therapeutic drugs/drugs of abuse IVD, control

Primary Device ID	B80010029000020
NIH Device Record Key	356c1400-4037-4375-92c0-92549f8a7737
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRUGS OF ABUSE QC
Version Model Number	DA+ QC 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	B80010029000020 [Primary]
HIBCC	B80010029000021 [Package] Package: Box [4 Units] In Commercial Distribution
HIBCC	B80010029000022 [Package] Package: Box [5 Units] In Commercial Distribution
HIBCC	B80010029000023 [Package] Package: Box [10 Units] In Commercial Distribution
HIBCC	B80010029000026 [Package] Package: Box [25 Units] In Commercial Distribution
HIBCC	B80010029000027 [Package] Package: Box [50 Units] In Commercial Distribution
HIBCC	B80010029000028 [Package] Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

B80010029000020	DA+ QC M LB
B800DAUQCFNSPCL5	DRUGS OF ABUSE QC