Home GUDID 00862011000321 Accelerate Pheno™ System
Primary DI 00862011000321
Brand Accelerate Pheno™ System
Company ACCELERATE DIAGNOSTICS, INC.
Model 10301008
Device description The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples.Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents.
Published 2017-03-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name PEN Gram-Negative Bacteria And Associated Resistance Markers PRH Positive Blood Culture Identification And Ast Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PEN Gram-Negative Bacteria And Associated Resistance Markers Microbiology 2 PRH Positive Blood Culture Identification And Ast Kit Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10862011000328 Package GS1 1 In Commercial Distribution 00862011000321 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 10862011000328 10862011000328 00862011000321 00862011000321 862011000321 0862011000321
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.
Regulatory Flags# DUNS number 186328670 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00862011000383 Accelerate PhenoTest BC kit 10104018 2021-11-04 10862011000335 Accelerate PhenoTest BC ID QC test 10105158 2018-02-01 10862011000342 Accelerate PhenoTest BC AST QC test 10106158 2018-02-01 00862011000352 Accelerate PhenoTest® BC AST QC test 10107158 2020-07-15 00862011000369 Accelerate PhenoTest® BC kit 10102018 2020-07-15 00862011000307 Accelerate PhenoTest™ BC Kit 10101018 2017-03-20 00862011000314 Accelerate Pheno™ System 10401008 2017-03-20
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 00862011000383 Accelerate PhenoTest BC kit ACCELERATE DIAGNOSTICS, INC. PRH 2021-11-04 00862011000352 Accelerate PhenoTest® BC AST QC test ACCELERATE DIAGNOSTICS, INC. PRH 2020-07-15 00862011000369 Accelerate PhenoTest® BC kit ACCELERATE DIAGNOSTICS, INC. PRH 2020-07-15 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 10862011000335 Accelerate PhenoTest BC ID QC test ACCELERATE DIAGNOSTICS, INC. PRH 2018-02-01 10862011000342 Accelerate PhenoTest BC AST QC test ACCELERATE DIAGNOSTICS, INC. PRH 2018-02-01 00862011000307 Accelerate PhenoTest™ BC Kit ACCELERATE DIAGNOSTICS, INC. PRH 2017-03-20 00862011000314 Accelerate Pheno™ System ACCELERATE DIAGNOSTICS, INC. PRH 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