Antigen, Positive Control, Cryptococcus Neoformans

Device Code: 3370

Product Code(s): JWK

Device Classification Information

Device Type ID3370
Device NameAntigen, Positive Control, Cryptococcus Neoformans
Regulation DescriptionCryptococcus Neoformans Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3165 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJWK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3370
DeviceAntigen, Positive Control, Cryptococcus Neoformans
Product CodeJWK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCryptococcus Neoformans Serological Reagents.
CFR Regulation Number866.3165 [🔎]
TPLC Last Update: 2019-04-02 20:28:22

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