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U.S. FDA Medical Device Chromatography (Thin Layer) Requirements

FDA Medical Device Definition: 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.

Registrar Corp assists Chromatography (Thin Layer) companies with:

  • FDA Chromatography (Thin Layer) Establishment Registration
  • FDA Chromatography (Thin Layer) Listing
  • FDA Chromatography (Thin Layer) Label Requirements and Exceptions
  • FDA Chromatography (Thin Layer) Import Information
  • FDA Chromatography (Thin Layer) Detentions (Chromatography (Thin Layer) Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Chromatography (Thin Layer) Manufacturers (Chromatography (Thin Layer) Suppliers)
       - Chromatography (Thin Layer) Distributors
       - Chromatography (Thin Layer) Processors
       - Chromatography (Thin Layer) Repackers
       - Chromatography (Thin Layer) Relabelers
       - Chromatography (Thin Layer) Exporters
       - Chromatography (Thin Layer) Importers
For more information about Chromatography (Thin Layer) Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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