U.S. FDA Medical Device pH Dye-Indicator Requirements
FDA Medical Device Definition: A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.
FDA pH Dye-Indicator Label Requirements and Exceptions
FDA pH Dye-Indicator Import Information
FDA pH Dye-Indicator Detentions (pH Dye-Indicator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- pH Dye-Indicator Manufacturers (pH Dye-Indicator Suppliers)
- pH Dye-Indicator Distributors
- pH Dye-Indicator Processors
- pH Dye-Indicator Repackers
- pH Dye-Indicator Relabelers
- pH Dye-Indicator Exporters
- pH Dye-Indicator Importers
For more information about pH Dye-Indicator 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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