3 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
×
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
FDA Enforcement
Class III
·Terminated·Arrow International Inc·February 4, 2015
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Enforcement
Class III
·Terminated·GSK Consumer Healthcare·July 20, 2016
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
FDA Enforcement
Class III
·Terminated·Quantimetrix Corporation·June 27, 2018