Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

Device Code: 3183

Product Code(s): GNH

Device Classification Information

Device Type ID3183
Device NameAntigen, Fluorescent Antibody Test, Schistosoma Mansoni
Regulation DescriptionSchistosoma Spp. Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3600 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGNH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3183
DeviceAntigen, Fluorescent Antibody Test, Schistosoma Mansoni
Product CodeGNH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSchistosoma Spp. Serological Reagents.
CFR Regulation Number866.3600 [🔎]
TPLC Last Update: 2019-04-02 20:25:13

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