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GMD — Antisera, Latex Agglutination, Cryptococcus Neoformans Class II

FDA Device Classification

Classification Details

Product Code
GMD
Device Class
Class II
Regulation Number
866.3165
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K112422immuno-mycologicsCRAG LATERAL FLOW ASSAY (LFA)March 28, 2012
K102286immuno-mycologicsCRAG LATERAL FLOW ASSAY (CRAG LFA)July 20, 2011
K930418trinity laboratoriesCRYPTO-LEX SYSTEMFebruary 17, 1994
K933997alexon biomedicalPROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYNovember 22, 1993
K894845meridian diagnostics(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASESeptember 8, 1989
K812188american scientific productsCRYPTOCOCCAL ANTIGEN LATEX AGGLUTIAugust 31, 1981
K810510immuno-mycologicsYA-CRYPTO ANTIBODY TUBE AGGLUTINATIONMarch 20, 1981
K792693meridian diagnosticsCRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEXJanuary 21, 1980
K791382immuno-mycologicsCRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATIONAugust 16, 1979
K780526i mCRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEMApril 28, 1978