TRACE ELEMENTS LEVEL 3 V2 TRACE 3 V2 S QD

GUDID B800TRACE3V2SQD5

TRACE ELEMENTS LEVEL 3 V2

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800TRACE3V2SQD5
• NIH Device Record Key: fa4cc1ff-f2a6-4c01-91e1-150f727cb6e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACE ELEMENTS LEVEL 3 V2
• Version Model Number: TRACE 3 V2 S QD
• Catalog Number: TRACE 3 V2 S QD
• 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: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com
• Phone: 18888825522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800TRACE3V2SQD0 [Primary]
HIBCC	B800TRACE3V2SQD5 [Package]; Contains: B800TRACE3V2SQD0; Package: BOX [25 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: 2025-03-10
• Device Publish Date: 2025-02-28

Devices Manufactured by UTAK LABORATORIES, INC.

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• B800STER2SMXSFSRL5 - ENDO LEVEL 2: 2025-04-23 ENDO LEVEL 2
• B800STER3SMXSFSRL5 - ENDO LEVEL 3: 2025-04-23 ENDO LEVEL 3
• B800SMXCSFFCP5 - SMX CEREBRAL SPINAL FLUID 1ML: 2025-04-10 SMX CEREBRAL SPINAL FLUID 1ML
• B800DAUQC1V2FBILH5 - DRUGS OF ABUSE QC 1: 2025-04-09 DRUGS OF ABUSE QC 1
• B800DAUQC3V2FBILH5 - DRUGS OF ABUSE QC 3: 2025-04-09 DRUGS OF ABUSE QC 3
• B800DAQCHIGHUFUMHC5 - DRUGS OF ABUSE QC HIGH: 2025-04-07 DRUGS OF ABUSE QC HIGH
• B800DAQCLOWUFUMHC5 - DRUGS OF ABUSE QC LOW: 2025-04-07 DRUGS OF ABUSE QC LOW