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U.S. FDA Medical Device Xylose Colorimetric 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 Colorimetric companies with:

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