For the quantitative determination of human fibrinogen in plasma.

For the quantitative determination of human fibrinogen in plasma.
K-ASSAY® Fibrinogen Reagent + Calibrator - KAI-035

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GIS

Device Name: Test, Fibrinogen

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.7340

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00816426020214

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A