Home GUDID 08426950448310 QUANTA Lite® GPA ELISA
Primary DI 08426950448310
Brand QUANTA Lite® GPA ELISA
Company INOVA DIAGNOSTICS, INC.
Model 708765
Device description (Gastric Parietal Cell Antibody) 1.1x GPA ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted GPA ELISA Low Positive4.1x 1.2mL prediluted GPA ELISA High Positive5.1x 50mL HRP Sample Diluent 6.1x 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 MLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08426950448310 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950448310 08426950448310 8426950448310
GMDN Terms# Term, Definition table Term Definition Intrinsic factor/parietal cell antibody 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 antibodies to intrinsic factor and/or parietal cells in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of conditions associated with deficiencies in intrinsic factor and/or parietal cell function/production such as autoimmune gastric disorders (e.g., pernicious anaemia, chronic atrophic gastritis), funicular myelosis, and various autoimmune endocrinopathies.
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 00816879020106 Autostat II Anti-Gastric Parietal Cell HYCOR BIOMEDICAL LLC MLE 2016-09-26
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