Drugs of Abuse Level 1 98818

GUDID B800988185

Drugs of Abuse Level 1 (WB)

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control

• Primary Device ID: B800988185
• NIH Device Record Key: 3d10f283-419d-47fb-b62e-0b52b8584e87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drugs of Abuse Level 1
• Version Model Number: 98818
• Catalog Number: 98818
• 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: 888-882-5522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 5 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800988180 [Primary]
HIBCC	B800988185 [Package]; Contains: B800988180; 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: 2020-04-23
• Device Publish Date: 2020-04-15

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• B800DAU1FSD5: DRUGS OF ABUSE LEVEL 1
• B800DAU1FHCMC5: DRUGS OF ABUSE LEVEL 1
• B800DAU1V2FAPS5: DRUGS OF ABUSE LEVEL 1
• B800DAOF1FADX5: DRUGS OF ABUSE LEVEL 1
• B800DA1V2WBNJSP0: DRUGS OF ABUSE LEVEL 1
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