Home GUDID B769ICCAAJA00000 iC-GPC Assay
Primary DI B769ICCAAJA00000
Brand iC-GPC Assay
Company ICUBATE, INC
Model iCC-AAJA00000
Device description The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci.
Published 2019-07-10
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 PAM Gram-Positive Bacteria And Their Resistance Markers
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PAM Gram-Positive Bacteria And Their Resistance Markers Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B769ICCAAJA00000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry 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 types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry 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 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 00840487101858 LIAISON PLEX Gram-Positive Blood Culture Assay LUMINEX CORPORATION PAM 2025-07-11 00815381020345 BioFire® Blood Culture Identification 2 (BCID2) Panel BIOFIRE DIAGNOSTICS, LLC PAM 2025-02-18 00815381020338 BioFire® Blood Culture Identification 2 (BCID2) Panel BIOFIRE DIAGNOSTICS, LLC PAM 2020-07-02 00840487101575 Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge LUMINEX CORPORATION PAM 2019-12-05 00840487101629 Gram-Positive Blood Culture (BC-GP) Extraction Tray LUMINEX CORPORATION PAM 2019-12-05 00840487101674 Gram-Positive Blood Culture (BC-GP) Utility Tray LUMINEX CORPORATION PAM 2019-12-05 00857167005283 ePlex GENMARK DIAGNOSTICS, INC. PAM 2019-08-22 00857167005290 ePlex GENMARK DIAGNOSTICS, INC. PAM 2019-08-22 00857167005306 ePlex GENMARK DIAGNOSTICS, INC. PAM 2019-08-22 00857167005313 ePlex GENMARK DIAGNOSTICS, INC. PAM 2019-08-22 00857167005320 ePlex GENMARK DIAGNOSTICS, INC. PAM 2019-08-22 00857167005337 ePlex GENMARK DIAGNOSTICS, INC. PAM 2019-08-22 B178GBSIDR100 Staph ID/R Blood Culture Panel GREAT BASIN SCIENTIFIC, INC. PAM 2016-09-23 00857573006119 Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge NANOSPHERE, INC. PAM 2016-09-23 00857573006218 Gram-Positive Blood Culture (BC-GP) Extraction Tray NANOSPHERE, INC. PAM 2016-09-23 00857573006287 Gram-Positive Blood Culture (BC-GP) Utility Tray NANOSPHERE, INC. PAM 2016-09-23 00815381020086 FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC PAM 2016-09-23 00815381020093 FilmArray® BCID Panel BIOFIRE DIAGNOSTICS, LLC PAM 2016-09-23
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