Antigen, Cf, B. Dermatitidis

Device Code: 3373

Product Code(s): JWW

Device Classification Information

Device Type ID3373
Device NameAntigen, Cf, B. Dermatitidis
Regulation DescriptionBlastomyces Dermatitidis Serological Reagents.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.3060 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJWW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3373
DeviceAntigen, Cf, B. Dermatitidis
Product CodeJWW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBlastomyces Dermatitidis Serological Reagents.
CFR Regulation Number866.3060 [🔎]
TPLC Last Update: 2019-04-02 20:28:25

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