DBM · Class II · 21 CFR 866.5090

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

Leading manufacturers include Inova Diagnostics, Inc., Zeus Scientific, Inc. and Elias U.S.A., 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 Oct 27, 2005
QUANTA LITE M2 EP (MIT3) ELISA
K052262
Inova Diagnostics, Inc.
Immunology · 69d
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 11, 1993
AYNELISA M2-ANTIBODIES
K930143
Elias U.S.A., Inc.
Immunology · 119d
Cleared Jun 15, 1983
AUTOANTIBODY SCREEN TEST SYSTEM
K831358
Zeus Scientific, Inc.
Microbiology · 50d
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 May 25, 1979
TEST KIT, IIF-AMA
K790295
Medica Corp.
Immunology · 105d
Cleared Jul 20, 1976
TEST, (IVDP) MITOCHONDRIAL ANTIBODY
K760155
Zeus Scientific, Inc.
Immunology · 18d

About Product Code DBM - Regulatory Context