System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

Device Code: 3050

Product Code(s): MSV

Device Classification Information

Device Type ID3050
Device NameSystem,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Regulation DescriptionMultiple Autoantibodies Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMSV
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3050
DeviceSystem,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Product CodeMSV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMultiple Autoantibodies Immunological Test System.
CFR Regulation Number866.5660 [🔎]
Premarket Reviews
ManufacturerDecision
IMMCO DIAGNOSTICS, INC.
 
SUBSTANTIALLY EQUIVALENT
1
INOVA DIAGNOSTICS, INC.
 
SUBSTANTIALLY EQUIVALENT
2
PHADIA AB
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:23:06

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