For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin

For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin
Berichrom® Heparin LMW Calibrator - 10445987

A material which is used to establish known points of reference for an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JPA

Device Name: System, Multipurpose For In Vitro Coagulation Studies

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: 864.5425

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00842768006845

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

Device Id: 00842768019210

Device Type: Unit of Use

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