DRUGS OF ABUSE LEVEL 1

GUDID B80002041000011

Multiple therapeutic drugs/drugs of abuse IVD, control

Primary Device ID	B80002041000011
NIH Device Record Key	01e0f030-6c0f-40ee-b790-702567d83c0c
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRUGS OF ABUSE LEVEL 1
Version Model Number	DA 1 S IDC
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	B80002041000010 [Primary]
HIBCC	B80002041000011 [Package] Contains: B80002041000010 Package: Box [4 Units] In Commercial Distribution
HIBCC	B80002041000012 [Package] Contains: B80002041000010 Package: Box [5 Units] In Commercial Distribution
HIBCC	B80002041000013 [Package] Contains: B80002041000010 Package: Box [10 Units] In Commercial Distribution
HIBCC	B80002041000016 [Package] Contains: B80002041000010 Package: Box [25 Units] In Commercial Distribution
HIBCC	B80002041000017 [Package] Contains: B80002041000010 Package: Box [50 Units] In Commercial Distribution
HIBCC	B80002041000018 [Package] Contains: B80002041000010 Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false