System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

PEX · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3361

Classification

FDA Product Code: PEX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3361
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 5

Source

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