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Procleix NAT Manager

BIOMEDICAL DATA SOLUTIONS LIMITED · Model 1.2 · UDI-DI 05060496770011

PQQ Prescription
0
510(k) clearances
0
Adverse events
1
Recalls
11
Facilities

Description

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.

Recalls

DateFirmReason
2016-12-22Tosoh Smd IncPower outages causes reporting software to shutdown.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.