Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.

Device Code: 3166

Product Code(s): GMO

Device Classification Information

Device Type ID3166
Device NameAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
Regulation DescriptionEntamoeba Histolytica Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3220 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGMO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3166
DeviceAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
Product CodeGMO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEntamoeba Histolytica Serological Reagents.
CFR Regulation Number866.3220 [🔎]
TPLC Last Update: 2019-04-02 20:24:52

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