Sera, Reactive And Non-specific Control, Fta-abs Test

Device Code: 3169

Product Code(s): GMR

Device Classification Information

Device Type ID3169
Device NameSera, Reactive And Non-specific Control, Fta-abs Test
Regulation DescriptionTreponema Pallidum Treponemal Test Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3830 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGMR
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 ID3169
DeviceSera, Reactive And Non-specific Control, Fta-abs Test
Product CodeGMR
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTreponema Pallidum Treponemal Test Reagents.
CFR Regulation Number866.3830 [🔎]
TPLC Last Update: 2019-04-02 20:24:55

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