SPECTROLYSE PAI-1 101201

GUDID 00850201006109

Biomedica ADI Inc.

Plasminogen activator inhibitor IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850201006109
• NIH Device Record Key: f730b420-1620-433e-94c5-5619e991496b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPECTROLYSE PAI-1
• Version Model Number: 101201
• Catalog Number: 101201
• Company DUNS: 080600606
• Company Name: Biomedica ADI Inc.
• 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: false
• 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	00850201006109 [Primary]

FDA Product Code

• GGP: TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

Devices Manufactured by Biomedica ADI Inc.

• 00850201006017 - DVVtest 10: 2018-03-29
• 00850201006024 - DVVconfirm 5: 2018-03-29
• 00850201006031 - ACTICHROME Heparin (Anti-FIIa): 2018-03-29
• 00850201006048 - IMUBIND PLASMA PAI-1 ELISA: 2018-03-29
• 00850201006055 - ACTICLOT dPT: 2018-03-29
• 00850201006062 - DVVtest 25: 2018-03-29
• 00850201006079 - ACTICHROME HEPARIN (ANTI-FXA): 2018-03-29
• 00850201006086 - ACTICHROME ATIII KIT: 2018-03-29