GLUCURONIDES HYDROLYSIS QC GLUC QC U CCHS

GUDID B800GLUCQCUCCHS5

GLUCURONIDES HYDROLYSIS QC

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800GLUCQCUCCHS5
• NIH Device Record Key: 06b35e10-8ba3-4eeb-9f72-2cb9049a7e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUCURONIDES HYDROLYSIS QC
• Version Model Number: GLUC QC U CCHS
• Catalog Number: GLUC QC U CCHS
• 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
• 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: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800GLUCQCUCCHS0 [Primary]
HIBCC	B800GLUCQCUCCHS5 [Package]; Contains: B800GLUCQCUCCHS0; Package: BOX [5 Units]; In Commercial Distribution

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: 2023-11-28
• Device Publish Date: 2023-11-20

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• B800THC2WB2PTFSDHL5 - THC PLUS LEVEL 2: 2025-06-19 THC PLUS LEVEL 2
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• B800MPA2SVPOTM5 - MPA LEVEL 2: 2025-05-28 MPA LEVEL 2
• B800MPA3SVPOTM5 - MPA LEVEL 3: 2025-05-28 MPA LEVEL 3
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