Product code DBM
- Device name
- Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5090
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181556 | EliA M2 Immunoassay | Phadia AB | 2018-07-13 |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | Inova Diagnostics, Inc. | 2017-09-05 |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | 2017-08-08 |
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | Phadia US, Inc. | 2015-02-13 |
| K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) | Euroimmun Us, Inc. | 2010-09-02 |
| K052262 | QUANTA LITE M2 EP (MIT3) ELISA | Inova Diagnostics, Inc. | 2005-10-27 |
| K031308 | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | Rhigene, Inc. | 2003-09-26 |
| K030238 | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | The Binding Site, Ltd. | 2003-03-24 |
| K982121 | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | Trace Scientific , Ltd. | 1998-09-17 |
| K971909 | VIRGO AMA ELISA KIT | Hemagen Diagnostics, Inc. | 1997-06-20 |
| K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | Hycor Biomedical, Inc. | 1996-11-25 |
| K945607 | VARELISA M2 ANTIBODIES | Elias U.S.A., Inc. | 1995-01-24 |
| K940251 | MITOCHONDRIA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-03 |
| K930143 | AYNELISA M2-ANTIBODIES | Elias U.S.A., Inc. | 1993-05-11 |
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | Shield Diagnostics, Ltd. | 1992-06-19 |
| K843181 | AUTOFLUOR IV SYSTEM | Tech America Diagnostics | 1984-09-17 |
| K842247 | MELOY AUTOANTIBODY TEST SYS | Meloy Laboratories, Inc. | 1984-06-26 |
| K831358 | AUTOANTIBODY SCREEN TEST SYSTEM | Zeus Scientific, Inc. | 1983-06-15 |
| K831100 | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | Medical Diagnostics, Ca. | 1983-05-04 |
| K810984 | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | Immuno-Products Industries | 1981-05-01 |
| K810863 | KALLESTAD HEP-2 CELL LINE SUBSTRATE | Kallestad Laboratories, Inc. | 1981-04-14 |
| K802308 | T/K (ATA/AMA) UNIVERSAL BIOPAK | Bioware Products | 1980-12-01 |
| K800821 | AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY | Calbiochem-Behring Corp. | 1980-04-24 |
| K800229 | IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT | Clinical Sciences, Inc. | 1980-02-21 |
| K790295 | TEST KIT, IIF-AMA | Medica Corp. | 1979-05-25 |
| K771993 | AFT SYSTEM | Calbiochem | 1977-11-02 |
| K760155 | TEST, (IVDP) MITOCHONDRIAL ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 |
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|---|---|---|---|
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| 07333066014333 | EliA M2 Positive Control 2500/5000 | Phadia AB | 2020-12-09 |
| 07333066020402 | EliA Sample Diluent | Phadia AB | 2020-12-09 |
| 00813545026639 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026622 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026615 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026608 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026950 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 00813545026967 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 00813545026974 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 00813545026981 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 08426950730101 | QUANTA Flash® M2 (MIT3) Reagents | INOVA DIAGNOSTICS, INC. | 2018-01-26 |
| 00845714002502 | Immco Diagnostics, Inc. | IMMCO DIAGNOSTICS, INC. | 2017-09-07 |
| 00845714002526 | Immco Diagnostics, Inc. | IMMCO DIAGNOSTICS, INC. | 2017-09-07 |
| 04049016124894 | EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016124887 | EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016027157 | Anti-M2-3E ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 07333066014852 | EliA M2 Well | Phadia AB | 2016-09-23 |
| 07333066010908 | EliA M2 Well | Phadia AB | 2016-09-23 |
| 05391516743839 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-22 |
| 00847865001618 | Kallestad | Bio-RAD Laboratories, Inc. | 2016-09-12 |
| 00847865001205 | Kallestad | Bio-RAD Laboratories, Inc. | 2016-09-12 |
| 00847865001588 | Kallestad | Bio-RAD Laboratories, Inc. | 2016-09-12 |
| 00847865001595 | Kallestad | Bio-RAD Laboratories, Inc. | 2016-09-12 |
| 00847865001601 | Kallestad | Bio-RAD Laboratories, Inc. | 2016-09-12 |
| 00847817016257 | Kallestad | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950596301 | QUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594239 | QUANTA Lite® PBC Screen IgG/IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593119 | QUANTA Lite® M2 EP (MIT3) ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 07340058410417 | DIASTAT anti-Mitochondrial | Svar Life Science AB | 2016-08-12 |