Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2

Device Code: 3065

Product Code(s): NOE

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 Analys

Device Classification Information

Device Type ID3065
Device NameTest, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Regulation DescriptionLow-density Lipoprotein Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5600 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNOE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3065
DeviceTest, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Product CodeNOE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionLow-density Lipoprotein Immunological Test System.
CFR Regulation Number866.5600 [🔎]
Premarket Reviews
ManufacturerDecision
DIADEXUS, INC.
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:23:19

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