Antigen, Cf (including Cf Control), Epstein-barr Virus

Device Code: 3192

Product Code(s): GNQ

Device Classification Information

Device Type ID3192
Device NameAntigen, Cf (including Cf Control), Epstein-barr Virus
Regulation DescriptionEpstein-Barr Virus Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3235 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGNQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID3192
DeviceAntigen, Cf (including Cf Control), Epstein-barr Virus
Product CodeGNQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEpstein-Barr Virus Serological Reagents.
CFR Regulation Number866.3235 [🔎]
TPLC Last Update: 2019-04-02 20:25:23

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