Mass Spectrometry, Microorganism Identification, Blood Culture

QNJ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3378

Classification

FDA Product Code: QNJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3378
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

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