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).
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.
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