Accelerate PhenoTest BC AST QC test

GUDID 10862011000342

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.

ACCELERATE DIAGNOSTICS, INC.

Multiple-type bloodstream pathogen nucleic acid IVD, control

• Primary Device ID: 10862011000342
• NIH Device Record Key: d78973e4-9641-4ed2-ad89-419a94a2dca1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelerate PhenoTest BC AST QC test
• Version Model Number: 10106158
• Company DUNS: 186328670
• Company Name: ACCELERATE DIAGNOSTICS, INC.
• Device Count: 5
• 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	00862011000345 [Unit of Use]
GS1	10862011000342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160032

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-12-21
• Device Publish Date: 2018-02-01

Devices Manufactured by ACCELERATE DIAGNOSTICS, INC.

• 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: 2020-12-21The 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.
• 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