Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and…
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
Who Else Makes It
Registered in Guangdong.
Record
Regulatory record for Procleix NAT Manager | Listed by | Biomedical Data Solutions Limited, United Kingdom |
| FDA product code | PQQ |
| Device type | Data Acquisition Software |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Manufacturer, Exporter |
| 510(k) | BK160125 |
| Record published | 2018-10-02 |
| Record revised | 2025-03-20 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
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.