Fibrotek 70-410

GUDID 00859394006040

Fibrinogen assay 100 DET

R 2 DIAGNOSTICS, INC.

Fibrinogen assay (factor I) IVD, kit, clotting

• Primary Device ID: 00859394006040
• NIH Device Record Key: 66e55df2-d77d-4c53-934d-4f614535f860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibrotek
• Version Model Number: 70-410
• Catalog Number: 70-410
• Company DUNS: 956610125
• Company Name: R 2 DIAGNOSTICS, 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: 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	00859394006040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042919

FDA Product Code

• KQJ: System, Fibrinogen Determination

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-15

Devices Manufactured by R 2 DIAGNOSTICS, INC.

• 00859394006040 - Fibrotek: 2018-07-06Fibrinogen assay 100 DET
• 00859394006040 - Fibrotek: 2018-07-06 Fibrinogen assay 100 DET
• 00859394006095 - ThromboTek PSe: 2018-07-06 Protein S Kit 80-160 DET