Antigens, All Groups, Salmonella Spp.

Device Code: 3277

Product Code(s): GRL

Device Classification Information

Device Type ID3277
Device NameAntigens, All Groups, Salmonella Spp.
Regulation DescriptionSalmonella 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 Number866.3550 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGRL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3277
DeviceAntigens, All Groups, Salmonella Spp.
Product CodeGRL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSalmonella Spp. Serological Reagents.
CFR Regulation Number866.3550 [🔎]
TPLC Last Update: 2019-04-02 20:26:57

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