For the calibration of the K-ASSAY® Factor XIII assay.

For the calibration of the K
K-ASSAY® Factor XIII Calibrator - KAI-106C

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of coagulation factor XIII in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DBT

Device Name: Factor Xiii A, S, Antigen, Antiserum, Control

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 866.5330

Third Party Flag: N

Medical Specialty: IM

Device Id: 00816426020719

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