Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology · 21 CFR 866.5090
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Bio-Rad LaboratoriesTerminatedSep 19, 2008
Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA
The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
Z-2428-2008 · View FDA record ↗ - Diasorin Inc.TerminatedApr 6, 2005
Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
Z-0673-05 · View FDA record ↗
Registered firms
29 firms currently registered for this product code
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Zeus Scientific Llc
BRANCHBURG, NJ, US
Hemagen Diagnostics, Inc.
Baltimore, MD, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Phadia Ab
UPPSALA, SE
Steris Schweiz Ag
Daniken Solothurn, CH
Phadia Us Inc.
Portage, MI, US
Svar Life Science Ab
MALMO Skane, SE
Bio-rad Laboratories, Inc.
Hercules, CA, US
Trinity Biotech Usa
Jamestown, NY, US
510(k) clearances
27 clearances for this product code
- Phadia ABJul 13, 2018
K181556 · EliA M2 Immunoassay
- Inova Diagnostics, Inc.Sep 5, 2017
K163525 · QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- Immco Diagnostics, Inc.Aug 8, 2017
K163133 · ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
- Phadia US, Inc.Feb 13, 2015
K141375 · ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
- Euroimmun Us, Inc.Sep 2, 2010
K092736 · EUROIMMUN ANTI-M2-3E ELISA (IGG)
- Inova Diagnostics, Inc.Oct 27, 2005
K052262 · QUANTA LITE M2 EP (MIT3) ELISA
- Rhigene, Inc.Sep 26, 2003
K031308 · RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
- The Binding Site, Ltd.Mar 24, 2003
K030238 · BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT