Antisera, Fluorescent, Echovirus 1-34

Device Code: 3276

Product Code(s): GRK

Device Classification Information

Device Type ID3276
Device NameAntisera, Fluorescent, Echovirus 1-34
Regulation DescriptionEchovirus Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3205 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGRK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3276
DeviceAntisera, Fluorescent, Echovirus 1-34
Product CodeGRK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEchovirus Serological Reagents.
CFR Regulation Number866.3205 [🔎]
TPLC Last Update: 2019-04-02 20:26:55

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