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U.S. FDA Medical Device Xylose P-Bromoaniline Requirements

FDA Medical Device Definition: A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).

Registrar Corp assists Xylose P-Bromoaniline companies with:

  • FDA Xylose P-Bromoaniline Establishment Registration
  • FDA Xylose P-Bromoaniline Listing
  • FDA Xylose P-Bromoaniline Label Requirements and Exceptions
  • FDA Xylose P-Bromoaniline Import Information
  • FDA Xylose P-Bromoaniline Detentions (Xylose P-Bromoaniline Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Xylose P-Bromoaniline Manufacturers (Xylose P-Bromoaniline Suppliers)
       - Xylose P-Bromoaniline Distributors
       - Xylose P-Bromoaniline Processors
       - Xylose P-Bromoaniline Repackers
       - Xylose P-Bromoaniline Relabelers
       - Xylose P-Bromoaniline Exporters
       - Xylose P-Bromoaniline Importers
For more information about Xylose P-Bromoaniline 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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