BUSULFAN CALIBRATOR LEVEL 1 V2 BUS CAL 1 V2 DP F MDACC

GUDID B800BUSCAL1V2DPFMDACC5

BUSULFAN CALIBRATOR LEVEL 1 V2

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800BUSCAL1V2DPFMDACC5
• NIH Device Record Key: f3f0b218-7de8-43b2-af69-c5db3fdbb341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUSULFAN CALIBRATOR LEVEL 1 V2
• Version Model Number: BUS CAL 1 V2 DP F MDACC
• Catalog Number: BUS CAL 1 V2 DP F MDACC
• 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

Device Dimensions

• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B800BUSCAL1V2DPFMDACC0 [Primary]
HIBCC	B800BUSCAL1V2DPFMDACC5 [Package]; Contains: B800BUSCAL1V2DPFMDACC0; Package: BOX [34 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: 2024-04-01
• Device Publish Date: 2024-03-22

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