Gamma Globulin, Antigen, Antiserum, Control

Device Code: 2898

Product Code(s): DAH

Device Classification Information

Device Type ID2898
Device NameGamma Globulin, Antigen, Antiserum, Control
Regulation DescriptionImmunoglobulins A, G, M, D, And E Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5510 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDAH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2898
DeviceGamma Globulin, Antigen, Antiserum, Control
Product CodeDAH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImmunoglobulins A, G, M, D, And E Immunological Test System.
CFR Regulation Number866.5510 [🔎]
TPLC Last Update: 2019-04-02 20:20:50

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