For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.

For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.
K-ASSAY® Apo AI Reagent - KAI-002

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DER

Device Name: Alpha-1-Lipoprotein, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5580

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00816426020016

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