3 results
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Sources: EU EUDAMED, US FDA
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Country: Canada
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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
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
400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
FDA Enforcement
Class II
·Terminated·ErgoSafe Product LLC dba Prism Medical Services·April 16, 2014