Accelerate PhenoTest® BC AST QC test

GUDID 00862011000352

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 bloodstream pathogen nucleic acid IVD, control

• Primary Device ID: 00862011000352
• NIH Device Record Key: 8eae1d16-c714-4693-80b8-1d3557d39b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelerate PhenoTest® BC AST QC test
• Version Model Number: 10107158
• 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	00862011000352 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-23
• Device Publish Date: 2020-07-15

Devices Manufactured by ACCELERATE DIAGNOSTICS, INC.

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• 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: 2020-07-23The 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.
• 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
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• 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