Transferrin, Fitc, Antigen, Antiserum, Control

Device Code: 2936

Product Code(s): DDI

Device Classification Information

Device Type ID2936
Device NameTransferrin, Fitc, Antigen, Antiserum, Control
Regulation DescriptionTransferrin Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5880 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDDI
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 ID2936
DeviceTransferrin, Fitc, Antigen, Antiserum, Control
Product CodeDDI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTransferrin Immunological Test System.
CFR Regulation Number866.5880 [🔎]
TPLC Last Update: 2019-04-02 20:21:27

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