Albumin, Fitc, Antigen, Antiserum, Control

Device Code: 2946

Product Code(s): DDZ

Device Classification Information

Device Type ID2946
Device NameAlbumin, Fitc, Antigen, Antiserum, Control
Regulation DescriptionAlbumin 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 Number866.5040 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDDZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2946
DeviceAlbumin, Fitc, Antigen, Antiserum, Control
Product CodeDDZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAlbumin Immunological Test System.
CFR Regulation Number866.5040 [🔎]
TPLC Last Update: 2019-04-02 20:21:34

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