4 results
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66ms
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Sources: EU EUDAMED, US FDA
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Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 20, 2017
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
FDA Enforcement
Class II
·Terminated·Abbott GmBH & Co. KG·December 4, 2019
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·March 23, 2016
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·February 1, 2017