3 results
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6ms
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Sources: EU EUDAMED, US FDA
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.
FDA Enforcement
Class II
·Terminated·The Binding Site Group, Ltd.·March 18, 2020
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
FDA Enforcement
Class II
·Terminated·Numed Inc·May 21, 2025
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
FDA Enforcement
Class II
·Terminated·DJO, LLC·July 10, 2013