Antiserum, Fluorescent, Rabies Virus

Device Code: 3208

Product Code(s): GOI

Device Classification Information

Device Type ID3208
Device NameAntiserum, Fluorescent, Rabies Virus
Regulation DescriptionRabiesvirus Immunofluorescent Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3460 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGOI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3208
DeviceAntiserum, Fluorescent, Rabies Virus
Product CodeGOI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRabiesvirus Immunofluorescent Reagents.
CFR Regulation Number866.3460 [🔎]
TPLC Last Update: 2019-04-02 20:25:40

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