DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Class II

FDA Device Classification

Classification Details

Product Code
DBM
Device Class
Class II
Regulation Number
866.5090
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K181556phadiaEliA M2 ImmunoassayJuly 13, 2018
K163525inova diagnosticsQUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MITSeptember 5, 2017
K163133immco diagnosticsImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM AntiAugust 8, 2017
K141375phadia usELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250February 13, 2015
K092736euroimmun usEUROIMMUN ANTI-M2-3E ELISA (IGG)September 2, 2010
K052262inova diagnosticsQUANTA LITE M2 EP (MIT3) ELISAOctober 27, 2005
K031308rhigeneRHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760September 26, 2003
K030238binding siteBINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KITMarch 24, 2003
K982121trace scientificENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTSeptember 17, 1998
K971909hemagen diagnosticsVIRGO AMA ELISA KITJune 20, 1997
K962452hycor biomedicalHY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIANovember 25, 1996
K945607elias u.s.aVARELISA M2 ANTIBODIESJanuary 24, 1995
K940251david a. fuccillo, ph.dMITOCHONDRIA EIA TEST KITMay 3, 1994
K930143elias u.s.aAYNELISA M2-ANTIBODIESMay 11, 1993
K921183shield diagnosticsDIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITJune 19, 1992
K843181tech america diagnosticsAUTOFLUOR IV SYSTEMSeptember 17, 1984
K842247meloy laboratoriesMELOY AUTOANTIBODY TEST SYSJune 26, 1984
K831358zeus scientificAUTOANTIBODY SCREEN TEST SYSTEMJune 15, 1983
K831100medical diagnostics, caMEDICA IIF-MULTIPLE ANTIBODY TEST KITMay 4, 1983
K810984immuno-products industriesANTIMITOCHONDRIAL IMMUNOFLUORESCENT TESTMay 1, 1981