US Biotek Laboratories DBK001

GUDID 00860010959244

Single-use convenient dried blood spot collection kit includes dry blood spot card, lancets and return packing for mailing to testing laboratory.

U.S. Biotek Laboratories LLC

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• Primary Device ID: 00860010959244
• NIH Device Record Key: 8e494d31-f172-4857-9b96-eb87768896c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US Biotek Laboratories
• Version Model Number: 1.0
• Catalog Number: DBK001
• 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	00860010959244 [Primary]

FDA Product Code

• OIA: Neonatal Blood Collection Kit And Screening Form (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

On-Brand Devices [US Biotek Laboratories]

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• 00860010959244: Single-use convenient dried blood spot collection kit includes dry blood spot card, lancets and
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