Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
FDA product code DBM · 26 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.5090
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-07-20 – 2018-07-13
DBM
2018-07-13
DBM
2017-09-05
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
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DBM
2017-08-08
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
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DBM
2010-09-02
EUROIMMUN ANTI-M2-3E ELISA (IGG)
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DBM
2005-10-27
QUANTA LITE M2 EP (MIT3) ELISA
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DBM
2003-09-26
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
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DBM
2003-03-24
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
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DBM
1998-09-17
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
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DBM
1997-06-20
VIRGO AMA ELISA KIT
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DBM
1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
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DBM
1995-01-24
VARELISA M2 ANTIBODIES
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DBM
1994-05-03
MITOCHONDRIA EIA TEST KIT
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DBM
1993-05-11
AYNELISA M2-ANTIBODIES
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DBM
1992-06-19
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
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DBM
1984-09-17
AUTOFLUOR IV SYSTEM
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DBM
1984-06-26
MELOY AUTOANTIBODY TEST SYS
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DBM
1983-06-15
AUTOANTIBODY SCREEN TEST SYSTEM
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DBM
1983-05-04
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT
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DBM
1981-05-01
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST
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DBM
1981-04-14
KALLESTAD HEP-2 CELL LINE SUBSTRATE
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DBM
1980-12-01
T/K (ATA/AMA) UNIVERSAL BIOPAK
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DBM
1980-04-24
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
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DBM
1980-02-21
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
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DBM
1979-05-25
TEST KIT, IIF-AMA
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DBM
1977-11-02
AFT SYSTEM
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DBM
1976-07-20
TEST, (IVDP) MITOCHONDRIAL ANTIBODY
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