Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.)

Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.)
Lyphochek - 597

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GGN

Device Name: Plasma, Coagulation Control

Device Class: 2

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: 864.5425

Third Party Flag: N

Medical Specialty: HE

Device Id: 00847661001027

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