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Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
FDA product code DBM · Class 2 · Immunology
48
Registered devices
1
Adverse events
2
Recalls
27
510(k) clearances
Devices with this code
EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) — EUROIMMUN Medizinische Labordiagnostika AGKallestad — Bio-RAD Laboratories, Inc.MA MS KDYTest(L) 48 Test — SCIMEDX CORPORATIONQUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack — INOVA DIAGNOSTICS, INC.Kallestad — Bio-RAD Laboratories, Inc.EliA Sample Diluent — Phadia ABTrinity Biotech — CLARK LABORATORIES, INC.MeDiCa — SCIMEDX CORPORATIONImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.Kallestad — Bio-RAD Laboratories, Inc.Anti-M2-3E ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGKallestad — Bio-RAD Laboratories, Inc.Kallestad — Bio-RAD Laboratories, Inc.QUANTA Lite® M2 EP (MIT3) ELISA — INOVA DIAGNOSTICS, INC.M. KDY Pack 8 WELL — SCIMEDX CORPORATIONKallestad — Bio-RAD Laboratories, Inc.Kallestad — Bio-RAD Laboratories, Inc.R. KDY Pack 8 WELL — SCIMEDX CORPORATIONDIASTAT anti-Mitochondrial — Svar Life Science ABMA MS KDY Test(L) 96 Test — SCIMEDX CORPORATIONImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.Kallestad — Bio-RAD Laboratories, Inc.MeDiCa — SCIMEDX CORPORATIONBio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-07-29 | Bio-Rad Laboratories | 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 |
| 2004-04-12 | Diasorin Inc. | 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 |
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