Home GUDID 00816387020230 IMMY
Primary DI 00816387020230
Brand IMMY
Company Immuno-Mycologics, Inc.
Model C60110
Device description Candida ID Positive Control
Published 2016-09-24
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 LSG Candida Species, Antibody Detection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LSG Candida Species, Antibody Detection Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816387020230 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816387020230 00816387020230 816387020230 0816387020230
GMDN Terms# Term, Definition table Term Definition Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to the yeast Candida albicans in a clinical specimen.
Regulatory Flags# DUNS number 099550915 Device count 1 Premarket exempt 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 10634853000206 Fungal Serology MICROBIOLOGICS INC. LSG 2022-09-26 10634853000213 Fungal Serology MICROBIOLOGICS INC. LSG 2022-09-26 04048474034585 Candida albicans IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSG 2019-06-05 00404847434583 Candida albicans IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSG 2019-06-05 00840239034588 Candida albicans IgG ELISA DRG International Inc LSG 2019-03-20 04049016067771 Anti-Candida albicans IFA (IgA) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067788 Anti-Candida albicans IFA (IgA) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067795 Anti-Candida albicans IFA (IgA) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067801 Anti-Candida albicans IFA (IgA) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067856 Anti-Candida albicans IFA (IgM) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067863 Anti-Candida albicans IFA (IgM) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067870 Anti-Candida albicans IFA (IgM) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067887 Anti-Candida albicans IFA (IgM) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016081715 Anti-Candida albicans IFA (IgA) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-10-10 04049016067818 Anti-Candida albicans IFA (IgG) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-09-24 04049016067825 Anti-Candida albicans IFA (IgG) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-09-24 04049016067832 Anti-Candida albicans IFA (IgG) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-09-24 04049016067849 Anti-Candida albicans IFA (IgG) EUROIMMUN Medizinische Labordiagnostika AG LSG 2016-09-24 00816387020223 IMMY Immuno-Mycologics, Inc. LSG 2016-09-24 00816387020797 IMMY Immuno-Mycologics, Inc. LSG 2016-09-24
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