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Tag Archives: Instrumentation Laboratory—

Chemiluminescent assay for HIT, 1/18

January 2018—Instrumentation Laboratory announced FDA 510(k) clearance of the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls. The assay is an on-demand, fully automated chemiluminescent reagent for use on hemostasis testing systems for the qualitative detection of platelet factor 4 (PF4)-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia.

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IL launches GemWeb Plus 500, 9/17

September 2017—Instrumentation Laboratory launched its customized connectivity solution, GemWeb Plus 500. From its dashboard, GemWeb Plus 500 offers complete control of Gem Premier critical care testing systems, including Gem Premier 5000 with Intelligent Quality Management 2, as well as connectivity to non-IL-manufactured devices at the point of care. GemWeb Plus 500 is accessible from tablet devices, PCs, and any networked analyzer.

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On-demand assay for heparin-induced thrombocytopenia, 10/16

October 2016—Instrumentation Laboratory introduced several innovations in hemostasis at the meeting, including the FDA 510(k)-cleared HemosIL HIT-Ab(PF4-H) assay for use on ACL Top Family Hemostasis Testing Systems. The fully automated, on-demand assay for heparin-induced thrombocytopenia detects antibodies associated with HIT on a hemostasis testing system.

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Hemostasis testing systems, 1/16

January 2016—Instrumentation Laboratory announced the 510(k) clearance of its ACL TOP Family 50 Series Hemostasis Testing Systems. Designed for mid- to high-volume clinical laboratories, including those using lab automation tracks, the ACL TOP Family 50 Series systems, comprising five models, offer preanalytical quality assurance, risk-management, and laboratory accreditation benefits.

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FDA clears IL’s hemostasis testing systems

Dec. 29, 2015—Bedford, Mass.-based Instrumentation Laboratory has received 510(k) clearance of their latest innovation, the ACL TOP Family 50 Series Hemostasis Testing Systems. The systems are designed for mid- to-high-volume clinical laboratories, including those using lab automation tracks. Commercialization in the U.S. will commence in 2016. The ACL TOP Family 50 Series systems have automated preanalytical sample integrity checks to ...

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