Carcinoembryonic Antigen Test System Suppliers
www.adilinstruments.com | Send Inquiry | Phone: +03-(88)-197050
FDA Registration: 9615711
Products: Microplate Washers, Manual Microplate Washers, Automated Microplate Washer, Elisa Assay Microplate Washers, Microtiter Diluting/Dispensing Device (FDA Code: JTC), Staphylococcus Aureus Protein A Insoluble (FDA Code: LHJ), ...
Adil Instruments specializes in microplate washers. Our LP21 is a simple automatique washer that has 8- or 12-channel manifold. Our LP41 high precision washer is available with an automatic rinsing fo more...
www.il-nl.com | Send Inquiry | Phone: +32-(2)-725-20-52
Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Automated Coagulation Analyzer (FDA Code: GKP), Blood Gas/pH analyzer, Centrifugal Chemistry Analyzer (FDA Code: JJG), Electrolyte Chemistry Analyzer, Programmable Multi-Channel Chemistry Analyzer, Therapeutic Drug Monitor Chemistry Analyzer, ...
Instrumentation Laboratory (Belgium) N.V./S.A is a developer, manufacturer and distributor of in vitro diagnostic instruments, reagents, controls, consumables & services for use primarily in hospitals more...
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.
