Flow Cytometry Calibrator

PDX · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5220

Classification

FDA Product Code: PDX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.5220
Review panel: IM
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 2

Source

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