LEFLUNOMIDE HIGH LEVEL 3 LEFLU HIGH L3

GUDID B800LEFLUHIGHL35

LEFLUNOMIDE HIGH LEVEL 3

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 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: B800LEFLUHIGHL35
• NIH Device Record Key: 14c8aad0-1bb0-48cb-9258-635d96ed0ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEFLUNOMIDE HIGH LEVEL 3
• Version Model Number: LEFLU HIGH L3
• Catalog Number: LEFLU HIGH L3
• 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: true
• 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: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 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
• 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	B800LEFLUHIGHL30 [Primary]
HIBCC	B800LEFLUHIGHL35 [Package]; Contains: B800LEFLUHIGHL30; 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: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [LEFLUNOMIDE HIGH LEVEL 3]

• B800LEFLUHIGHL35: LEFLUNOMIDE HIGH LEVEL 3
• B800LEFLUHIGHL3V25: LEFLUNOMIDE HIGH LEVEL 3