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MJH — Legionella, Spp., Elisa Class II

FDA Device Classification

Classification Details

Product Code
MJH
Device Class
Class II
Regulation Number
866.3300
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191184ssi diagnosticaImmuView S pneumoniae and L pneumophila Urinary Antigen TestMarch 5, 2020
K163273meridian bioscienceTRU LegionellaFebruary 21, 2017
K113190meridian bioscienceTRU LEGIONELLAFebruary 24, 2012
K061496sa scientificSAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TESTJune 28, 2007
K070522inverness medical professional diagnosticsMODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012March 15, 2007
K033051trinity biotech usaLEGIONELLA PNEUMOPHILA IGG/IGMNovember 26, 2003
K991074intracelBARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTDecember 21, 1999
K982238binaxBINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLAugust 21, 1998
K934965binaxBINAX LEGIONELLA URINARY ANTIGEN EIASeptember 20, 1994
K911356whittaker bioproductsLEGIONELLA STAT IGG/IGM TEST KITJuly 30, 1992