Home GUDID B769ICCAAQA00000 iC-GN Assay
Primary DI B769ICCAAQA00000
Brand iC-GN Assay
Company ICUBATE, INC
Model iCC-AAQA00000
Device description The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli.
Published 2019-07-15
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 PEN Gram-Negative Bacteria And Associated Resistance Markers
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PEN Gram-Negative Bacteria And Associated Resistance Markers Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B769ICCAAQA00000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple bacterial bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple bacterial species associated with bloodstream infection in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 830140377 Device count 1 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 00840487101841 LIAISON PLEX Gram-Negative Blood Culture Assay LUMINEX CORPORATION PEN 2025-06-11 00815381020345 BioFire® Blood Culture Identification 2 (BCID2) Panel BIOFIRE DIAGNOSTICS, LLC PEN 2025-02-18 00815381020338 BioFire® Blood Culture Identification 2 (BCID2) Panel BIOFIRE DIAGNOSTICS, LLC PEN 2020-07-02 00840487101599 Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge LUMINEX CORPORATION PEN 2019-12-05 00840487101643 Gram-Negative Blood Culture (BC-GN) Extraction Tray LUMINEX CORPORATION PEN 2019-12-05 00840487101698 Gram-Negative Blood Culture (BC-GN) Utility Tray LUMINEX CORPORATION PEN 2019-12-05 00857167005283 ePlex GENMARK DIAGNOSTICS, INC. PEN 2019-08-22 00857167005290 ePlex GENMARK DIAGNOSTICS, INC. PEN 2019-08-22 00857167005306 ePlex GENMARK DIAGNOSTICS, INC. PEN 2019-08-22 00857167005313 ePlex GENMARK DIAGNOSTICS, INC. PEN 2019-08-22 00857167005320 ePlex GENMARK DIAGNOSTICS, INC. PEN 2019-08-22 00857167005337 ePlex GENMARK DIAGNOSTICS, INC. PEN 2019-08-22 00862011000321 Accelerate Pheno™ System ACCELERATE DIAGNOSTICS, INC. PEN 2017-03-20 00857573006140 Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge NANOSPHERE, INC. PEN 2016-09-23 00857573006249 Gram-Negative Blood Culture (BC-GN) Extraction Tray NANOSPHERE, INC. PEN 2016-09-23 00857573006300 Gram-Negative Blood Culture (BC-GN) Utility Tray NANOSPHERE, INC. PEN 2016-09-23 00815381020086 FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC PEN 2016-09-23 00815381020093 FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC PEN 2016-09-23
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