Data Acquisition Software

PQQ · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.2570

Classification

FDA Product Code: PQQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.2570
Review panel: MI
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 10

Source

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