Autoantibodies, Skin (desmoglein 1 And Desmoglein 3)

Device Code: 3056

Product Code(s): NBO

Device Classification Information

Device Type ID3056
Device NameAutoantibodies, Skin (desmoglein 1 And Desmoglein 3)
Regulation DescriptionMultiple Autoantibodies Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNBO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3056
DeviceAutoantibodies, Skin (desmoglein 1 And Desmoglein 3)
Product CodeNBO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMultiple Autoantibodies Immunological Test System.
CFR Regulation Number866.5660 [🔎]
TPLC Last Update: 2019-04-02 20:23:11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.