Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility…
Bloodstream Software is a standalone software application used in blood screening. Bloodstream Software may be configured to connect to instrumentation in a blood screening facility including pipetting systems (poolers), automation software (a track system), blood testing instrumentation, and Laboratory Information Systems (LIS). Bloodstream Software also contains a user interface (UI) that allows users of Bloodstream Software to monitor the testing progress of donor samples in their lab, as well as allowing limited interaction in the testing process, such as modifying or canceling orders, or reviewing and approving results.
Who Else Makes It
Registered in Guangdong.
Record
Regulatory record for Bloodstream Software | Listed by | Data Innovations, LLC, United States |
| FDA product code | PQQ |
| Device type | Data Acquisition Software |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-29 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.