Antiserum, Cf, Rubeola

Device Code: 3271

Product Code(s): GRF

Device Classification Information

Device Type ID3271
Device NameAntiserum, Cf, 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 CodeGRF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3271
DeviceAntiserum, Cf, Rubeola
Product CodeGRF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRubeola (measles) Virus Serological Reagents.
CFR Regulation Number866.3520 [🔎]
TPLC Last Update: 2019-04-02 20:26:47

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