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Accelerate Pheno™ System

FDA UDI

Class II (US FDA UDI)

by Accelerate Diagnostics, Inc.

Identity

Trade Name
Accelerate Pheno™ System FDA UDI
Generic Name
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry FDA UDI
Device Name
The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples. Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents. FDA UDI
Model / Reference
10401008 FDA UDI
Description
The Accelerate Pheno™ system is a fully-integrated in vitro diagnostic system comprised of one to four module(s), a Control PC, Analysis PC(s), touchscreen monitor and Accelerate Pheno system software for use with Accelerate PhenoTest™ kits. It is designed to perform identification (ID) and quantitation of bacterial and yeast cells in less than 90 minutes and antimicrobial susceptibility testing (AST) on average in less than 7 hours directly from patient samples. Identification uses fluorescence in situ hybridization (FISH) and susceptibility testing uses microscopic observation of individual, live, growing bacterial cells in near real time (approximately every 10 minutes) in the presence of antimicrobial agents. FDA UDI

Identifiers

Primary DI / UDI-DI
00862011000314 FDA UDI
510(k) Number
DEN160032 FDA UDI
FDA Product Code
PRH FDA UDI
GMDN Term
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

Accelerate Pheno™ System 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, kit, nucleic acid amplification/mass spectrometry.

Cleared under the same submission

DEN160032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accelerate Diagnostics, Inc.

Sources (1)

  • FDA UDI 06494a30-6dbe-4321-b7be-644dd2505cfd 34 fields · synced May 30, 2026