3 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
FDA Enforcement
Class II
·Terminated·Medtest Holdings, Inc.·June 7, 2017
Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
FDA Enforcement
Class II
·Terminated·Medtest Holdings, Inc.·July 6, 2016
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
FDA Enforcement
Class II
·Terminated·Medtest Holdings, Inc.·June 21, 2017