Kit, Identification, Dermatophyte

Device Code: 3349

Product Code(s): JSR

Device Classification Information

Device Type ID3349
Device NameKit, Identification, Dermatophyte
Regulation DescriptionMicroorganism Differentiation And Identification Device.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.2660 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJSR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3349
DeviceKit, Identification, Dermatophyte
Product CodeJSR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicroorganism Differentiation And Identification Device.
CFR Regulation Number866.2660 [🔎]
TPLC Last Update: 2019-04-02 20:28:03

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