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U.S. FDA Medical Device Obstetric pH Paper 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 Obstetric pH Paper companies with:

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