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Accelerate PhenoTest BC kit

FDA UDI

Class II (US FDA UDI)

by Accelerate Diagnostics, Inc.

Identity

Trade Name
Accelerate PhenoTest BC kit FDA UDI
Generic Name
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry FDA UDI
Device Name
The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification (ID/AST configuration) and quantitative, antimicrobial susceptibility testing (AST) methods (ID/AST and AST configurations) and is intended for use with the Accelerate Pheno® system. The Accelerate PhenoTest® BC kit is capable of simultaneous detection and identification of multiple microbial targets (ID/AST configuration) followed by susceptibility testing of the appropriate detected bacterial organisms (ID/AST and AST configuration). The Accelerate PhenoTest® BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. FDA UDI
Model / Reference
10104018 FDA UDI
Description
The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification (ID/AST configuration) and quantitative, antimicrobial susceptibility testing (AST) methods (ID/AST and AST configurations) and is intended for use with the Accelerate Pheno® system. The Accelerate PhenoTest® BC kit is capable of simultaneous detection and identification of multiple microbial targets (ID/AST configuration) followed by susceptibility testing of the appropriate detected bacterial organisms (ID/AST and AST configuration). The Accelerate PhenoTest® BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. FDA UDI

Identifiers

Primary DI / UDI-DI
00862011000383 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

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, kit, nucleic acid amplification/mass spectrometry

Accelerate PhenoTest BC kit 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.

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 af18becd-d205-4e89-93c9-5aeba83d954b 33 fields · synced Jun 8, 2026