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U.S. FDA Medical Device Breath Measurement System 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 Breath Measurement System companies with:

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