DBM · Class II · 21 CFR 866.5090

FDA Product Code DBM: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Elias U.S.A., Inc., Inova Diagnostics, Inc. and Zeus Scientific, Inc..

27
Total
27
Cleared
94d
Avg days
1976
Since

FDA 510(k) Cleared Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DBM)

27 devices
1–24 of 27
Cleared Jul 13, 2018
EliA M2 Immunoassay
K181556
Phadia AB
Immunology · 30d
Cleared Sep 05, 2017
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
K163525
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Aug 08, 2017
ImmuLisa Enhanced AMA IgG Antibody ELISA
K163133
Immco Diagnostics, Inc.
Immunology · 273d
Cleared Feb 13, 2015
ELIA M2
K141375
Phadia US, Inc.
Immunology · 262d
Cleared Sep 02, 2010
EUROIMMUN ANTI-M2-3E ELISA (IGG)
K092736
Euroimmun Us, Inc.
Immunology · 363d
Cleared Oct 27, 2005
QUANTA LITE M2 EP (MIT3) ELISA
K052262
Inova Diagnostics, Inc.
Immunology · 69d
Cleared Sep 26, 2003
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
K031308
Rhigene, Inc.
Immunology · 155d
Cleared Mar 24, 2003
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238
The Binding Site, Ltd.
Immunology · 60d
Cleared Sep 17, 1998
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121
Trace Scientific , Ltd.
Immunology · 93d
Cleared Jun 20, 1997
VIRGO AMA ELISA KIT
K971909
Hemagen Diagnostics, Inc.
Immunology · 28d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
K962452
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Jan 24, 1995
VARELISA M2 ANTIBODIES
K945607
Elias U.S.A., Inc.
Immunology · 70d
Cleared May 03, 1994
MITOCHONDRIA EIA TEST KIT
K940251
David A. Fuccillo, Ph.D.
Immunology · 104d
Cleared May 11, 1993
AYNELISA M2-ANTIBODIES
K930143
Elias U.S.A., Inc.
Immunology · 119d
Cleared Jun 19, 1992
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183
Shield Diagnostics, Ltd.
Immunology · 102d
Cleared Sep 17, 1984
AUTOFLUOR IV SYSTEM
K843181
Tech America Diagnostics
Immunology · 35d
Cleared Jun 26, 1984
MELOY AUTOANTIBODY TEST SYS
K842247
Meloy Laboratories, Inc.
Immunology · 20d
Cleared Jun 15, 1983
AUTOANTIBODY SCREEN TEST SYSTEM
K831358
Zeus Scientific, Inc.
Microbiology · 50d
Cleared May 04, 1983
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT
K831100
Medical Diagnostics, Ca.
Immunology · 29d
Cleared May 01, 1981
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST
K810984
Immuno-Products Industries
Immunology · 18d
Cleared Apr 14, 1981
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Apr 24, 1980
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Feb 21, 1980
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229
Clinical Sciences, Inc.
Immunology · 16d
Cleared May 25, 1979
TEST KIT, IIF-AMA
K790295
Medica Corp.
Immunology · 105d

About Product Code DBM - Regulatory Context