Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

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

Classification

FDA Product Code: QZX
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

Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 2

Source

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