Antiserum, Cf, Mumps Virus

Device Code: 3267

Product Code(s): GRB

Device Classification Information

Device Type ID3267
Device NameAntiserum, Cf, 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 CodeGRB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3267
DeviceAntiserum, Cf, Mumps Virus
Product CodeGRB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMumps Virus Serological Reagents.
CFR Regulation Number866.3380 [🔎]
TPLC Last Update: 2019-04-02 20:26:42

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