Home GUDID 00862011000352 Accelerate PhenoTest® BC AST QC test
Primary DI 00862011000352
Brand Accelerate PhenoTest® BC AST QC test
Company ACCELERATE DIAGNOSTICS, INC.
Model 10107158
Device description The Accelerate PhenoTest® BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the antimicrobial susceptibility test (AST) calls made by the Accelerate PhenoTest® BC kit. This quality control test is run in conjunction with the Accelerate PhenoTest® BC kit.
Published 2020-07-15
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 PRH Positive Blood Culture Identification And Ast Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PRH Positive Blood Culture Identification And Ast Kit Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00862011000352 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 00862011000352 00862011000352 862011000352 0862011000352
GMDN Terms# Term, Definition table Term Definition Multiple bloodstream pathogen nucleic acid IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.
Regulatory Flags# DUNS number 186328670 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration 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 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 00862011000321 Accelerate Pheno™ System 10301008 2017-03-20
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00862011000383 Accelerate PhenoTest BC kit ACCELERATE DIAGNOSTICS, INC. PRH 2021-11-04 00862011000369 Accelerate PhenoTest® BC kit ACCELERATE DIAGNOSTICS, INC. PRH 2020-07-15 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 00862011000321 Accelerate Pheno™ System ACCELERATE DIAGNOSTICS, INC. PRH 2017-03-20