Home GUDID 07333066010908 EliA M2 Well
Primary DI 07333066010908
Brand EliA M2 Well
Company Phadia AB
Model DECC056490
Catalog number DECC056490
Device description EliA M2 Well
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name DBM ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07333066010908 Package GS1 4 In Commercial Distribution 07333066014852 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07333066010908 07333066010908 7333066010908 07333066014852 07333066014852 7333066014852
GMDN Terms# Term, Definition table Term Definition Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies to mitochondria M2 (anti-Mi2) in a clinical specimen, using a fluorescent immunoassay method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 354019424 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07333066013206 EliA Sample Diluent Phadia AB DBM 2020-12-09 07333066020402 EliA Sample Diluent Phadia AB DBM 2020-12-09 07333066014333 EliA M2 Positive Control 2500/5000 Phadia AB DBM 2020-12-09 00813545026608 MeDiCa SCIMEDX CORPORATION DBM 2020-12-01 00813545026615 MeDiCa SCIMEDX CORPORATION DBM 2020-12-01 00813545026622 MeDiCa SCIMEDX CORPORATION DBM 2020-12-01 00813545026639 MeDiCa SCIMEDX CORPORATION DBM 2020-12-01 00813545026950 MeDiCa SCIMEDX CORPORATION DBM 2020-11-04 00813545026967 MeDiCa SCIMEDX CORPORATION DBM 2020-11-04 00813545026974 MeDiCa SCIMEDX CORPORATION DBM 2020-11-04 00813545026981 MeDiCa SCIMEDX CORPORATION DBM 2020-11-04 08426950730101 QUANTA Flash® M2 (MIT3) Reagents INOVA DIAGNOSTICS, INC. DBM 2018-01-26 00845714002502 Immco Diagnostics, Inc. IMMCO DIAGNOSTICS, INC. DBM 2017-09-07 00845714002526 Immco Diagnostics, Inc. IMMCO DIAGNOSTICS, INC. DBM 2017-09-07 04049016027157 Anti-M2-3E ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG DBM 2016-09-24 04049016124887 EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) EUROIMMUN Medizinische Labordiagnostika AG DBM 2016-09-24 04049016124894 EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) EUROIMMUN Medizinische Labordiagnostika AG DBM 2016-09-24 07333066014852 EliA M2 Well Phadia AB DBM 2016-09-23 05391516743839 Trinity Biotech CLARK LABORATORIES, INC. DBM 2016-09-22 00813545022273 MA(RK)48 Test(L) SCIMEDX CORPORATION DBM 2016-09-19 00813545022297 MA(RK)96 Test(L) SCIMEDX CORPORATION DBM 2016-09-19 00813545022303 MA MS KDYTest(L) 48 Test SCIMEDX CORPORATION DBM 2016-09-19 00813545022310 MA MS KDY Test(L) 96 Test SCIMEDX CORPORATION DBM 2016-09-19 00813545020279 R. KDY Pack 8 WELL SCIMEDX CORPORATION DBM 2016-09-13 00813545020286 M. KDY Pack 4 WELL SCIMEDX CORPORATION DBM 2016-09-13 00813545020293 R. KDY Pack 4 WELL SCIMEDX CORPORATION DBM 2016-09-13 00813545020309 M. KDY Pack 8 WELL SCIMEDX CORPORATION DBM 2016-09-13 00847817016257 Kallestad BIO-RAD LABORATORIES, INC. DBM 2016-09-12 00847865001205 Kallestad Bio-RAD Laboratories, Inc. DBM 2016-09-12 00847865001588 Kallestad Bio-RAD Laboratories, Inc. DBM 2016-09-12
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