DBM

Product Code: DBM


Products Classified as DBM

2919Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlAntimitochondrial Antibody Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2919Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlAntimitochondrial Antibody Immunological Test System.

Pre-market Notifications for DBM

K181556EliA M2 ImmunoassayPhadia AB
K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.
K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAIMMCO Diagnostics, Inc.
K141375ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250PHADIA US INC.
K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)EUROIMMUN US INC
K052262QUANTA LITE M2 EP (MIT3) ELISAINOVA DIAGNOSTICS, INC.
K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTTRACE SCIENTIFIC LTD.
K971909VIRGO AMA ELISA KITHEMAGEN DIAGNOSTICS, INC.
K962452HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIAHYCOR BIOMEDICAL, INC.
K945607VARELISA M2 ANTIBODIESELIAS USA, INC.
K940251MITOCHONDRIA EIA TEST KITDAVID A. FUCCILLO, PH.D.
K930143AYNELISA M2-ANTIBODIESELIAS USA, INC.
K921183DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KITSHIELD DIAGNOSTICS, LTD.
K843181AUTOFLUOR IV SYSTEMTECH AMERICA DIAGNOSTICS
K842247MELOY AUTOANTIBODY TEST SYSMELOY LABORATORIES, INC.

Global Unique Device Identification Database

00813545022310Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00813545022303Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00813545022297Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00813545022273Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00813545020309Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00813545020293Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00813545020286Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00813545020279Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
00847865019354ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
00847865017343ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
00847865017244ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
00847865001779ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
00847865001762ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
00847865001755ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
00847865001731ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

Maude Adverse Events

KALLSTEAD HEP-2 AND ANCABIO-RAD LABORATORIES, INC.2018-11-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.