Antiserum, Fluorescent, Mycobacterium Tuberculosis

Device Code: 3281

Product Code(s): GRT

Device Classification Information

Device Type ID3281
Device NameAntiserum, Fluorescent, Mycobacterium Tuberculosis
Regulation DescriptionMycobacterium Tuberculosis Immunofluorescent Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3370 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGRT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID3281
DeviceAntiserum, Fluorescent, Mycobacterium Tuberculosis
Product CodeGRT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMycobacterium Tuberculosis Immunofluorescent Reagents.
CFR Regulation Number866.3370 [🔎]
TPLC Last Update: 2019-04-02 20:27:00

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