US Biotek Laboratories UTK001

GUDID 00860010959220

Single-use convenient urine transport kit includes transport tube(s), and return packing for mailing to testing laboratory.

U.S. Biotek Laboratories LLC

Urine specimen collection kit IVD

• Primary Device ID: 00860010959220
• NIH Device Record Key: 06766202-fbb9-47a5-b339-5062959c79ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US Biotek Laboratories
• Version Model Number: 1.0
• Catalog Number: UTK001
• Company DUNS: 094709776
• Company Name: U.S. Biotek Laboratories LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010959220 [Primary]

FDA Product Code

• OHZ: Urine Transport Kit (Excludes Hiv Testing)

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: 2023-09-25
• Device Publish Date: 2023-09-15

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