Home GUDID 00857573006140 Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge
Primary DI 00857573006140
Brand Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge
Company NANOSPHERE, INC.
Model 20-006-021
Device description The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
Published 2016-09-23
Public version status Update
Distribution status Not 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 00840487101599 Primary GS1 0 00857573006140 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 00840487101599 00840487101599 840487101599 0840487101599 00857573006140 00857573006140 857573006140 0857573006140
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 164757242 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857573006027 Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge 20-006-001 2016-09-23 00857573006348 Hypercoagulation Panel (HC) Sample Buffer 30-001-001 2016-09-23 00857573006133 Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge 20-006-020 2016-09-23 00857573006164 Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge 20-006-024 2016-09-23 00857573006232 Respiratory Virus Plus (RV+) Extraction Tray 20-009-020 2016-09-23 00857573006263 Respiratory Pathogens Flex (RP Flex) Extraction Tray 20-009-024 2016-09-23 00857573006294 Respiratory Virus Plus (RV+) Amplification Tray 20-011-020 2016-09-23 00857573006324 Respiratory Pathogens Flex (RP Flex) Amplification Tray 20-011-024 2016-09-23 00857573006119 Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge 20-006-018 2016-09-23 00857573006218 Gram-Positive Blood Culture (BC-GP) Extraction Tray 20-009-018 2016-09-23 00857573006287 Gram-Positive Blood Culture (BC-GP) Utility Tray 20-011-018 2016-09-23 00857573006003 Verigene® Reader 10-0000-02 2016-09-23 00857573006010 Verigene® Processor SP 10-0000-07 2016-09-23 00857573006386 Verigene® Processor 10-0000-04 2016-09-23 00857573006393 Verigene® Reader (Refurbished) 10-0000-02R 2016-11-04 00857573006409 Verigene® Processor SP (Refurbished) 10-0000-07R 2016-11-04 00857573006041 Enteric Pathogens (EP) Nucleic Acid Test Cartridge 20-006-023 2016-09-23 00857573006058 Enteric Pathogens (EP) Extraction Tray 20-009-023 2016-09-23 00857573006065 Enteric Pathogens (EP) Stool Sample Preparation Kit 30-002-023 2016-09-23 00857573006089 Enteric Pathogens (EP) Amplification Tray 20-011-023 2016-09-23
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 B769ICCAAQA00000 iC-GN Assay ICUBATE, INC PEN 2019-07-15 00862011000321 Accelerate Pheno™ System ACCELERATE DIAGNOSTICS, INC. PEN 2017-03-20 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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