Kit, Identification, Neisseria Gonorrhoeae

Device Code: 3353

Product Code(s): JSX

Device Classification Information

Device Type ID3353
Device NameKit, Identification, Neisseria Gonorrhoeae
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 CodeJSX
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3353
DeviceKit, Identification, Neisseria Gonorrhoeae
Product CodeJSX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicroorganism Differentiation And Identification Device.
CFR Regulation Number866.2660 [🔎]
TPLC Last Update: 2019-04-02 20:28:06

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