Accelerate PhenoTest BC kit

GUDID 00862011000383

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.

ACCELERATE DIAGNOSTICS, INC.

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• Primary Device ID: 00862011000383
• NIH Device Record Key: af18becd-d205-4e89-93c9-5aeba83d954b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelerate PhenoTest BC kit
• Version Model Number: 10104018
• Company DUNS: 186328670
• Company Name: ACCELERATE DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862011000383 [Primary]

FDA Product Code

• PRH: Positive Blood Culture Identification And Ast Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-12
• Device Publish Date: 2021-11-04

Devices Manufactured by ACCELERATE DIAGNOSTICS, INC.

• 00862011000383 - Accelerate PhenoTest BC kit: 2021-11-12The 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.
• 00862011000383 - Accelerate PhenoTest BC kit: 2021-11-12 The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence
• 10862011000335 - Accelerate PhenoTest BC ID QC test: 2020-12-21 The Accelerate PhenoTest™ BC ID QC test is intended to serve as an external quality control to monitor the accuracy of the org
• 10862011000342 - Accelerate PhenoTest BC AST QC test: 2020-12-21 The Accelerate PhenoTest™ BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the an
• 00862011000352 - Accelerate PhenoTest® BC AST QC test: 2020-07-23 The Accelerate PhenoTest® BC AST QC test is intended to serve as an external quality control to monitor the accuracy of the ant
• 00862011000369 - Accelerate PhenoTest® BC kit: 2020-07-23 The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence
• 00862011000307 - Accelerate PhenoTest™ BC Kit: 2019-08-20 The Accelerate PhenoTest™ BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescenc
• 00862011000314 - Accelerate Pheno™ System: 2019-08-20 The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC
• 00862011000321 - Accelerate Pheno™ System: 2019-08-20 The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC