Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect

Russell Viper Venom
Factor V Leiden - 10873903

A collection of reagents and other associated materials intended to be used to determine the activated protein C resistance ratio (APCR) of a clinical specimen, using a clotting method to measure clotting time with and without added activated protein C.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GGW

Device Name: Test, Time, Partial Thromboplastin

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: 864.7925

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00630414639758

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