Kit, Identification, Pseudomonas

Device Code: 3355

Product Code(s): JSZ

Device Classification Information

Device Type ID3355
Device NameKit, Identification, Pseudomonas
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 CodeJSZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3355
DeviceKit, Identification, Pseudomonas
Product CodeJSZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicroorganism Differentiation And Identification Device.
CFR Regulation Number866.2660 [🔎]
TPLC Last Update: 2019-04-02 20:28:07

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