Molecular Testing Labs

GUDID 00850068539017

Swab with tube collection kit for respiratory testing

Blackfly Investments, LLC

Oral/upper respiratory tract specimen collection swab

• Primary Device ID: 00850068539017
• NIH Device Record Key: 2590d894-cb19-4e9e-9f48-34b5b2813a1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Molecular Testing Labs
• Version Model Number: Swab Collection Kit
• Company DUNS: 069497839
• Company Name: Blackfly Investments, 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850068539017 [Primary]

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: 2024-11-21
• Device Publish Date: 2024-11-13

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• 00860008357885: Dried Blood Spot and Neat Urine Collection Kit
• 00850068539000: Dried Blood Spot and Swab Collection Kit
• 00850068539017: Swab with tube collection kit for respiratory testing