Thyroglobulin, Antigen, Antiserum, Control

Device Code: 2933

Product Code(s): DDC

Device Classification Information

Device Type ID2933
Device NameThyroglobulin, Antigen, Antiserum, Control
Regulation DescriptionThyroid Autoantibody Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5870 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDDC
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2933
DeviceThyroglobulin, Antigen, Antiserum, Control
Product CodeDDC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionThyroid Autoantibody Immunological Test System.
CFR Regulation Number866.5870 [🔎]
TPLC Last Update: 2019-04-02 20:21:24

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