DRUGS OF ABUSE HIGH V4 DAU HIGH V4 3ML U IPM

GUDID B800DAUHIGHV43MLUIPM0

DRUGS OF ABUSE HIGH V4

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800DAUHIGHV43MLUIPM0
• NIH Device Record Key: 39490015-0b0a-4a93-895b-da2de1dd79c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRUGS OF ABUSE HIGH V4
• Version Model Number: DAU HIGH V4 3ML U IPM
• Catalog Number: DAU HIGH V4 3ML U IPM
• 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

Customer Support Contacts

• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com
• Phone: 1-888-882-5522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 9 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800DAUHIGHV43MLUIPM0 [Primary]

FDA Product Code

• LAS: Drug Specific Control Materials

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-05
• Device Publish Date: 2026-02-25

Devices Manufactured by UTAK LABORATORIES, INC.

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• B800DAUHIGHV43MLUIPM0 - DRUGS OF ABUSE HIGH V4: 2026-03-05DRUGS OF ABUSE HIGH V4
• B800DAUHIGHV43MLUIPM0 - DRUGS OF ABUSE HIGH V4: 2026-03-05 DRUGS OF ABUSE HIGH V4
• B800DAULOWV43MLUIPM5 - DRUGS OF ABUSE LOW V4: 2026-03-05 DRUGS OF ABUSE LOW V4
• B800DAUMIDV43MLUIPM0 - DRUGS OF ABUSE MID V4: 2026-03-05 DRUGS OF ABUSE MID V4
• B800ETH177WBFOSBI5 - ETHANOL 76 MG/DL: 2026-03-03 ETHANOL 76 MG/DL
• B800ETH76WBFOSBI5 - ETHANOL 76 MG/DL: 2026-03-03 ETHANOL 76 MG/DL
• B800ANTIF2SQD5 - ANTIFUNGALS LEVEL 2: 2026-02-16 ANTIFUNGALS LEVEL 2
• B800ANLCCALMFFCCO5 - ANLC CAL: 2026-02-13 ANLC CAL