Prostate-Specific Antigen for Management of Prostate Cancers Suppliers
FDA Registration: 9610529
Products: Automated Urinalysis System (FDA Code: KQO), Radioimmunoassay for Dehydroepiandrosterone Sulfate (FDA Code: JKC), Estradiol Radioimmunoassay Test (FDA Code: CHP), Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ), Hydroxyproline Chromatography Column Test (FDA Code: JMM), Total Triiodothyronine Radioimmunoassay (FDA Code: CDP), ...
Roche Diagnostics Gmbh Mannheim is a provider of automated urinalysis system and cardiac readers. more...
www.edap-tms.com | Send Inquiry | Phone: +33-(472)-153 150
Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ), Microwave Hyperthermia System (FDA Code: MEQ), Urological Extracorporeal Shock-wave Lithotriptor (FDA Code: LNS), Dual Isocentric and Motorized Imaging Systems, Electroconductive Shock-wave Lithotripters, Intuitive Localization Systems, ...
EDAP TMS S.A. develops, produces, markets and distributes minimally-invasive therapeutic solutions for urology. We specialize in therapeutic ultrasound. We provide minimally-invasive treatment for loc more...
1 [2]A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
