Home GUDID 20758750033604 VITROS
Primary DI 20758750033604
Brand VITROS
Company ORTHO CLINICAL DIAGNOSTICS
Model 6199951
Catalog number 6199951
Device description VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Reagent Pack
Published 2023-11-22
Public version status New
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 QVP SARS-CoV-2 serology test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVP Sars-Cov-2 Serology Test Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20758750033604 Package GS1 30 In Commercial Distribution 10758750033607 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20758750033604 20758750033604 10758750033607 10758750033607
GMDN Terms# Term, Definition table Term Definition SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not freeze Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 215865786 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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#