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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.

Registrar Corp assists pH Dye-Indicator companies with:

  • FDA pH Dye-Indicator Establishment Registration
  • FDA pH Dye-Indicator Listing
  • 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.

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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