2 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
FDA Recall
Open, Classified
·Aniara Diagnostica LLC·Product code LCO·April 1, 2026
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.
FDA Recall
Open, Classified
·Aniara Diagnostica LLC·Product code GGP·February 1, 2023