Antigen, Cf, Typhus Fever Group

Device Code: 3232

Product Code(s): GPO

Device Classification Information

Device Type ID3232
Device NameAntigen, Cf, Typhus Fever Group
Regulation DescriptionRickettsia Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGPO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3232
DeviceAntigen, Cf, Typhus Fever Group
Product CodeGPO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRickettsia Serological Reagents.
CFR Regulation Number866.3500 [🔎]
TPLC Last Update: 2019-04-02 20:26:06

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