Hemagglutination Inhibition, Gentamicin

Device Code: 6109

Product Code(s): DNO

Device Classification Information

Device Type ID6109
Device NameHemagglutination Inhibition, Gentamicin
Regulation DescriptionGentamicin Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3450 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDNO
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 ID6109
DeviceHemagglutination Inhibition, Gentamicin
Product CodeDNO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGentamicin Test System.
CFR Regulation Number862.3450 [🔎]
TPLC Last Update: 2019-04-02 21:17:24

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