Enable Blood Spot Collection Kit

GUDID 00860010987803

Sample Collection Kit Dried Blood Spot and Kit Accessories

Enable Biosciences Inc.

Capillary blood collection kit IVD

• Primary Device ID: 00860010987803
• NIH Device Record Key: 7e7f7c77-201e-4f39-86cb-ce5b12c2d245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enable Blood Spot Collection Kit
• Version Model Number: EBCK1
• Company DUNS: 079962225
• Company Name: Enable Biosciences 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010987803 [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: 2023-09-22
• Device Publish Date: 2023-09-14