Diazyme

Diazyme - 10-0148

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme phospholipase A2 in a clinical specimen, using a spectrophotometry method. It is used as an aid in the diagnosis and risk assessment of atherosclerotic diseases such as coronary artery disease and ischemic stroke.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NOE

Device Name: Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Device Class: 2

Physical State: N/A

Definition: The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein.

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: 866.5600

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00817089021433

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