Positive Blood Culture Identification And Ast Kit

PRH · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1650

Classification

FDA Product Code: PRH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.1650
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown