2 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·August 28, 2013
Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium complex 4.5 ng/mL; Rx only Product Usage: Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·April 6, 2016