For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
INNOVANCE Heparin - 10873535

A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KFF

Device Name: Assay, Heparin

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: 864.7525

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00842768017438

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