Antisera, Cf, Rubella

Device Code: 3212

Product Code(s): GOM

Device Classification Information

Device Type ID3212
Device NameAntisera, Cf, Rubella
Regulation DescriptionRubella Virus Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3510 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGOM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID3212
DeviceAntisera, Cf, Rubella
Product CodeGOM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRubella Virus Serological Reagents.
CFR Regulation Number866.3510 [🔎]
TPLC Last Update: 2019-04-02 20:25:45

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