DRUGS OF ABUSE PANEL DAU PAN OF F ODX

GUDID B800DAUPANOFFODX5

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	B800DAUPANOFFODX5
NIH Device Record Key	f44d7d5f-efc9-4067-92e0-3fc153b3e822
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRUGS OF ABUSE PANEL
Version Model Number	DAU PAN OF F ODX
Catalog Number	DAU PAN OF F ODX
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

Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and -10 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B800DAUPANOFFODX0 [Primary]
HIBCC	B800DAUPANOFFODX5 [Package] Contains: B800DAUPANOFFODX0 Package: BOX [30 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

B800DAMCALRDL5 - DRUGS OF ABUSE CAL	2025-09-12 DRUGS OF ABUSE CAL
B800DAMQCRDL5 - DRUGS OF ABUSE	2025-09-12 DRUGS OF ABUSE
B800VOL150MMC5 - VOLATILES 150 MG/DL	2025-09-03 VOLATILES 150 MG/DL
B800AED1V3SHCMC5 - AED LEVEL 1 V3	2025-09-02 AED LEVEL 1 V3
B800AED2V3SHCMC0 - AED LEVEL 2 V3	2025-09-02 AED LEVEL 2 V3
B800TESTOHIGHSFBRL5 - TESTOSTERONE PLUS HIGH	2025-09-02 TESTOSTERONE PLUS HIGH
B800TESTOLOWSFBRL5 - TESTOSTERONE PLUS LOW	2025-09-02 TESTOSTERONE PLUS LOW
B800DAUQCFNSPCL5 - DRUGS OF ABUSE QC	2025-09-01 DRUGS OF ABUSE QC