Data Acquisition Software
The Data Acquisition Software is laboratory software that integrates a network of sample pooling instruments and manages the overall blood analysis sample workflow, acquiring and processing data from donor screening, diagnostic, and multiplex assay instruments used in blood banking and transfusion medicine. It is classified as FDA Class 2 under 21 CFR 862.2570 in the Clinical Chemistry specialty, exempt from 510(k) submission requirements under the de novo or notification exemption pathway. Product code PQQ; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQQ
- Device Class
- FDA class 2
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.