An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.

An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.
APO B - LP3839

A collection of reagents and other associated materials intended to be used for the quantitative measurement of apolipoprotein B (Apo B) lipid in a clinical specimen, using a nephelometry/turbidimetry method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JHN

Device Name: Turbidimetric Method, Lipoproteins

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1475

Third Party Flag: N

Medical Specialty: CH

Device Id: 05055273204469

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