Antigens, Ha (including Ha Control), Reovirus 1-3

Device Code: 3242

Product Code(s): GQA

Device Classification Information

Device Type ID3242
Device NameAntigens, Ha (including Ha Control), Reovirus 1-3
Regulation DescriptionReovirus Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3470 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGQA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3242
DeviceAntigens, Ha (including Ha Control), Reovirus 1-3
Product CodeGQA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionReovirus Serological Reagents.
CFR Regulation Number866.3470 [🔎]
TPLC Last Update: 2019-04-02 20:26:18

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