Home GUDID 08426950593119 QUANTA Lite® M2 EP (MIT3) ELISA
Primary DI 08426950593119
Brand QUANTA Lite® M2 EP (MIT3) ELISA
Company INOVA DIAGNOSTICS, INC.
Model 704540
Device description 1. 1 M2 EP (MIT3) ELISA microwell plate (12-1 x 8 wells), with holder2. 1x.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted M2 EP (MIT3) ELISA Low Positive4. 1x 1.2mL prediluted M2 EP (MIT3) ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Published 2016-08-31
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 08426950593119 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950593119 08426950593119 8426950593119
GMDN Terms# Term, Definition table Term Definition Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) 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 an enzyme immunoassay (EIA) 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 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 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 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
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