Identity
- Trade Name
- Accelerate PhenoTest BC ID QC test FDA UDI
- Generic Name
- Multiple-type bloodstream pathogen nucleic acid IVD, control FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 10105158 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10862011000335 FDA UDI
- 510(k) Number
- DEN160032 FDA UDI
- FDA Product Code
- PRH FDA UDI
- GMDN Term
- Multiple-type bloodstream pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple-type bloodstream pathogen nucleic acid IVD, control
Accelerate PhenoTest BC ID QC test by Accelerate Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type bloodstream pathogen nucleic acid IVD, control.
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- Accelerate PhenoTest® BC AST QC test — Accelerate Diagnostics, Inc. · Class II
- Accelerate PhenoTest BC AST QC test — Accelerate Diagnostics, Inc. · Class II
Cleared under the same submission
DEN160032 also covers:
- Accelerate PhenoTest BC AST QC test — Accelerate Diagnostics, Inc.
- Accelerate PhenoTest® BC AST QC test — Accelerate Diagnostics, Inc.
- Accelerate PhenoTest® BC kit — Accelerate Diagnostics, Inc.
- Accelerate PhenoTest™ BC Kit — Accelerate Diagnostics, Inc.
- Accelerate Pheno™ System — Accelerate Diagnostics, Inc.
- Accelerate Pheno™ System — Accelerate Diagnostics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Accelerate Diagnostics, Inc.
Sources (1)
- FDA UDI 17da9547-4984-48a5-9597-212f6a7b43b2 34 fields · synced Jun 8, 2026