Accelerate Arc System
Accelerate Diagnostics, Inc.
ACCELERATE DIAGNOSTICS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010671651 | 3010671651 | ACCELERATE DIAGNOSTICS, INC. | 1 | N | 2020-04-25 | 3950 S COUNTRY CLUB RD STE 470 Tucson AZ US 85714 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 205399 | 1457808163 | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | PRH | 2017-02-23 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PRH | 1 | 2017-02-23 |
PMN#
Accelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc.
GUDID#
Accelerate PhenoTest BC kit - The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification (ID/AST configuration) and quantitative, antimicrobial susceptibility testing (AST) methods (ID/AST and AST configurations) and is intended for use with the Accelerate Pheno® system. The Accelerate PhenoTest® BC kit is capable of simultaneous detection and identification of multiple microbial targets (ID/AST configuration) followed by susceptibility testing of the appropriate detected bacterial organisms (ID/AST and AST configuration). The Accelerate PhenoTest® BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.
2021-11-04
Accelerate PhenoTest BC ID QC test - The Accelerate PhenoTest™ BC ID QC test is intended to serve as an external quality control to monitor the accuracy of the organism identification calls made by the Accelerate PhenoTest™ BC kit. This quality control test is run in conjunction with the Accelerate PhenoTest™ BC AST QC test and Accelerate PhenoTest™ BC kit.
2018-02-01
Accelerate PhenoTest BC AST QC test - 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.
2018-02-01
Accelerate PhenoTest® BC AST QC test - 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.
2020-07-15
Accelerate PhenoTest® BC kit - The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods and is intended for use with the Accelerate Pheno® system. The Accelerate PhenoTest® BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms. The ®Accelerate PhenoTest® BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.
2020-07-15
Accelerate PhenoTest™ BC Kit - The Accelerate PhenoTest™ BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods and is intended for use with the Accelerate Pheno™ system. The Accelerate PhenoTest™ BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms. The Accelerate PhenoTest™ BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.
2017-03-20
Accelerate Pheno™ System - 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.
2017-03-20
Accelerate Pheno™ System - 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.
2017-03-20