DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DBM
- Device Class
- Class II
- Regulation Number
- 866.5090
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K181556 | phadia | EliA M2 Immunoassay | July 13, 2018 |
| K163525 | inova diagnostics | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT | September 5, 2017 |
| K163133 | immco diagnostics | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Anti | August 8, 2017 |
| K141375 | phadia us | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | February 13, 2015 |
| K092736 | euroimmun us | EUROIMMUN ANTI-M2-3E ELISA (IGG) | September 2, 2010 |
| K052262 | inova diagnostics | QUANTA LITE M2 EP (MIT3) ELISA | October 27, 2005 |
| K031308 | rhigene | RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 | September 26, 2003 |
| K030238 | binding site | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | March 24, 2003 |
| K982121 | trace scientific | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT | September 17, 1998 |
| K971909 | hemagen diagnostics | VIRGO AMA ELISA KIT | June 20, 1997 |
| K962452 | hycor biomedical | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | November 25, 1996 |
| K945607 | elias u.s.a | VARELISA M2 ANTIBODIES | January 24, 1995 |
| K940251 | david a. fuccillo, ph.d | MITOCHONDRIA EIA TEST KIT | May 3, 1994 |
| K930143 | elias u.s.a | AYNELISA M2-ANTIBODIES | May 11, 1993 |
| K921183 | shield diagnostics | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | June 19, 1992 |
| K843181 | tech america diagnostics | AUTOFLUOR IV SYSTEM | September 17, 1984 |
| K842247 | meloy laboratories | MELOY AUTOANTIBODY TEST SYS | June 26, 1984 |
| K831358 | zeus scientific | AUTOANTIBODY SCREEN TEST SYSTEM | June 15, 1983 |
| K831100 | medical diagnostics, ca | MEDICA IIF-MULTIPLE ANTIBODY TEST KIT | May 4, 1983 |
| K810984 | immuno-products industries | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | May 1, 1981 |