Alpha-2-macroglobulin, Antigen, Antiserum, Control

Device Code: 2948

Product Code(s): DEB

Device Classification Information

Device Type ID2948
Device NameAlpha-2-macroglobulin, Antigen, Antiserum, Control
Regulation DescriptionAlpha-2-macroglobulin Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.5620 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDEB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID2948
DeviceAlpha-2-macroglobulin, Antigen, Antiserum, Control
Product CodeDEB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAlpha-2-macroglobulin Immunological Test System.
CFR Regulation Number866.5620 [🔎]
Premarket Reviews
ManufacturerDecision
THE BINDING SITE GROUP, LTD.
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:21:36

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