DRUGS OF ABUSE LOW V2 DAU LOW V2 F PG

GUDID B800DAULOWV2FPG5

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	B800DAULOWV2FPG5
NIH Device Record Key	3aa640dd-d76d-4ded-8760-ab4cf78a0140
Commercial Distribution Status	In Commercial Distribution
Brand Name	DRUGS OF ABUSE LOW V2
Version Model Number	DAU LOW V2 F PG
Catalog Number	DAU LOW V2 F PG
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
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	B800DAULOWV2FPG0 [Primary]
HIBCC	B800DAULOWV2FPG5 [Package] Contains: B800DAULOWV2FPG0 Package: BOX [25 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

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B800MPA3SVPOTM5 - MPA LEVEL 3	2025-05-28 MPA LEVEL 3
B800AMPH2UV4FWBH5 - AMPHETAMINE PLUS LEVEL 2 V4	2025-05-21 AMPHETAMINE PLUS LEVEL 2 V4
B800COT25SWDL5 - COTININE PLUS 25 NG/ML	2025-05-21 COTININE PLUS 25 NG/ML
B800COT5SWDL5 - COTININE PLUS 5 NG/ML	2025-05-21 COTININE PLUS 5 NG/ML
B800CREAALDD5 - CREATININE PLUS	2025-05-21 CREATININE PLUS
B800GABA1V3SMXUFPG5 - GABAPENTIN LEVEL 1	2025-05-16 GABAPENTIN LEVEL 1
B800GABA2V2SMXUFPG5 - GABAPENTIN LEVEL 2	2025-05-16 GABAPENTIN LEVEL 2