PRHClass II

Positive Blood Culture Identification And Ast Kit

21 CFR 866.1650 / Microbiology

PRH is the FDA product code for Positive Blood Culture Identification And Ast Kit, a class II device type, regulated under 21 CFR 866.1650. FDA's definition for this code reads: "Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2020-09-15, and 4 recalls.

Classification record

Product code: PRH
Device name: Positive Blood Culture Identification And Ast Kit
FDA definition: Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
Regulation: 21 CFR 866.1650
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 4

Clearances, product code PRH

By decision year

2 clearances under product code PRH with a decision year between 2017 and 2020, 2017 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PRH by decision year
Year	Clearances
2017	1
2020	1

Applicants with the most clearances

Product code PRH

Applicants holding the most 510(k) clearances under product code PRH
Applicant	Clearances
Accelerate Diagnostics, Inc.	1
Accelerate Diagnotics	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PRH.