XL-FDP agglutination reagent 800DB-LX

GUDID 00850201006185

Biomedica ADI Inc.

D-dimer IVD, kit, agglutination

• Primary Device ID: 00850201006185
• NIH Device Record Key: b3b98b5f-cdec-457d-ae32-7bdebf4c741e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XL-FDP agglutination reagent
• Version Model Number: 800DB-LX
• Catalog Number: 800DB-LX
• 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	00850201006185 [Primary]

FDA Product Code

• DAP: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

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