Product code PQQ

Device name

Data Acquisition Software

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.2570

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset