Antigens, Slide And Tube, All Types, Listeria Monocytogenes

Device Code: 3293

Product Code(s): GSI

Device Classification Information

Device Type ID3293
Device NameAntigens, Slide And Tube, All Types, Listeria Monocytogenes
Regulation DescriptionListeria Spp. Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3355 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGSI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3293
DeviceAntigens, Slide And Tube, All Types, Listeria Monocytogenes
Product CodeGSI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionListeria Spp. Serological Reagents.
CFR Regulation Number866.3355 [🔎]
TPLC Last Update: 2019-04-02 20:27:09

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