URINE BROAD PANEL HIGH

GUDID B30001346000010

Multiple therapeutic drugs/drugs of abuse IVD, control

Primary Device ID	B30001346000010
NIH Device Record Key	655e439b-3882-42b8-96d1-c2f6233aa1ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	URINE BROAD PANEL HIGH
Version Model Number	UBP H F V DU
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	B30001346000010 [Primary]
HIBCC	B30001346000011 [Package] Package: Box [4 Units] In Commercial Distribution
HIBCC	B30001346000012 [Package] Package: Box [5 Units] In Commercial Distribution
HIBCC	B30001346000013 [Package] Package: Box [10 Units] In Commercial Distribution
HIBCC	B30001346000016 [Package] Package: Box [25 Units] In Commercial Distribution
HIBCC	B30001346000017 [Package] Package: Box [50 Units] In Commercial Distribution
HIBCC	B30001346000018 [Package] Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false