Clinical Use Chromatography (Thin Layer) Suppliers
www.biodex.com | Send Inquiry | Phone: +1-(631)-924-9000
FDA Registration: 2431314 Year Established: 1949 Annual Revenues: USD 25-50 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Radiobiological Supply, Fitness Treadmills, Manual Treadmills, Exercise Treadmills, Fitness Equipment Treadmills, Cardiac Treadmills, ...
Biodex Medical Systems, Inc. specializes in medical equipment. We are an ISO certified company. Our products include physical medicine & rehabilitation, nuclear medicine supplies & accessories, & medi more...
A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9. Particular components of TLC systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
