Home GUDID 08426950730101 QUANTA Flash® M2 (MIT3) Reagents
Primary DI 08426950730101
Brand QUANTA Flash® M2 (MIT3) Reagents
Company INOVA DIAGNOSTICS, INC.
Model 701303
Device description 1. 1 QUANTA Flash M2 (MIT3) Reagent Cartridge2. 1 Resuspension buffer3. 1 Transfer pipette
Published 2018-01-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true 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 08426950730101 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950730101 08426950730101 8426950730101
GMDN Terms# Term, Definition table Term Definition Mitochondrial antibody M2 (anti-Mi2) IVD, kit, chemiluminescent 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 chemiluminescent immunoassay method. It is typically used to aid in the diagnosis of primary biliary cirrhosis.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 188354831 Device count 1 Kit true Lot or batch true Expiration date on label true 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 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 07333066010908 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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