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 Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type 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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• 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
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