PQQ — Data Acquisition Software Class II
FDA product code PQQ covers "Data Acquisition Software", a Class II medical device regulated under 21 CFR 862.2570. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- PQQ
- Device Class
- Class II
- Regulation Number
- 862.2570
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.