US Biotek Laboratories SCK001

GUDID 00860010959268

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

U.S. Biotek Laboratories LLC

Evacuated blood collection tube IVD, clot promoter

• Primary Device ID: 00860010959268
• NIH Device Record Key: 61455468-b475-44b7-9454-f6f0ea023086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US Biotek Laboratories
• Version Model Number: 1.0
• Catalog Number: SCK001
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010959268 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

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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