Antigen, Cf (including Cf Control), Mumps Virus

Device Code: 3268

Product Code(s): GRC

Device Classification Information

Device Type ID3268
Device NameAntigen, Cf (including Cf Control), Mumps Virus
Regulation DescriptionMumps Virus Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3380 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGRC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3268
DeviceAntigen, Cf (including Cf Control), Mumps Virus
Product CodeGRC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMumps Virus Serological Reagents.
CFR Regulation Number866.3380 [🔎]
TPLC Last Update: 2019-04-02 20:26:44

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