4 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
FDA Enforcement
Class II
·Ongoing·Accriva Diagnostics, Inc.·June 24, 2026
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
FDA Enforcement
Class II
·Ongoing·Accriva Diagnostics, Inc.·December 10, 2025
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
FDA Enforcement
Class II
·Ongoing·Accriva Diagnostics, Inc.·January 22, 2025
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
FDA Enforcement
Class III
·Ongoing·Accriva Diagnostics, Inc.·November 19, 2025