Antigen, Cf, Lymphocytic Choriomeningitis Virus

Device Code: 3252

Product Code(s): GQK

Device Classification Information

Device Type ID3252
Device NameAntigen, Cf, Lymphocytic Choriomeningitis Virus
Regulation DescriptionLymphocytic Choriomeningitis 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 Number866.3360 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGQK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3252
DeviceAntigen, Cf, Lymphocytic Choriomeningitis Virus
Product CodeGQK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLymphocytic Choriomeningitis Virus Serological Reagents.
CFR Regulation Number866.3360 [🔎]
TPLC Last Update: 2019-04-02 20:26:25

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