Analyser software IVDs

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Предлага се от:

Grifols Australia Pty Ltd

Клас:

Class 2

Произведено от:

Data Innovations LLC 463 Mountain View Drive, Colchester, VT, 05446 United States Of America

Терапевтична област:

CT1250 - Analyser software IVDs

Терапевтични показания:

Blood stream software is a standalone software used in blood screening, as a data management software. Bloodstream may be configured to connect to instrumentation in a blood screening facility including poolers, automation software (a track system), blood testing instrumentation, and a Laboratory Information System (LIS). Bloodstream also contains a user interface (UI) that allows users of bloodstream to monitor the testing progress of donations in their lab, as well as allowing limited interaction in the testing process such as modifying or cancelling orders, reviewing, and approving results. Management of test orders for a donor from a Laboratory Information System (LIS) ? Management of pools and testing assigned to pools ? Management of lysates and testing assigned to lysates ? Handling Order and Result communication to/from blood testing instrumentation ? Allows review, approval, and modification* of result data produced by blood testing instrumentation prior to sending it to the LIS (*NOTE: Modify the existing reports, and only as it relates to: cell data source, displayed columns, comments, layout or formatting, print options, and header and footer contents of the report. It does not pertain to actually changing or modifying the results or data.) ? Assignment of results from pools to the constituent donors contained within that pool ? Assignment of results from lysates to the constituent donor contained within that lysate ? Provides indications to the user of the health of the instrument and reagents used to produce a result ? Produces informational reports on the processing and handling of donations

Статус Оторизация:

A

Дата Оторизация:

2022-09-21