Antigens, Cf (including Cf Control), Equine Encephalitis Virus, Eee, Wee

Device Code: 3245

Product Code(s): GQD

Device Classification Information

Device Type ID3245
Device NameAntigens, Cf (including Cf Control), Equine Encephalitis Virus, Eee, Wee
Regulation DescriptionEquine Encephalomyelitis 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 Number866.3240 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGQD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3245
DeviceAntigens, Cf (including Cf Control), Equine Encephalitis Virus, Eee, Wee
Product CodeGQD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEquine Encephalomyelitis Virus Serological Reagents.
CFR Regulation Number866.3240 [🔎]
TPLC Last Update: 2019-04-02 20:26:20

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