Antiserum, Fluorescent, Rubeola

Device Code: 3270

Product Code(s): GRE

Device Classification Information

Device Type ID3270
Device NameAntiserum, Fluorescent, Rubeola
Regulation DescriptionRubeola (measles) 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 Number866.3520 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGRE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3270
DeviceAntiserum, Fluorescent, Rubeola
Product CodeGRE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRubeola (measles) Virus Serological Reagents.
CFR Regulation Number866.3520 [🔎]
TPLC Last Update: 2019-04-02 20:26:46

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