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U.S. FDA Medical Device Cystine Chromatographic Requirements


FDA Medical Device Definition: A cystine test system is a device intended to measure the amino acid cystine in urine. Cystine measurements are used in the diagnosis of cystinuria (occurrence of cystine in urine). Patients with cystinuria frequently develop kidney calculi (stones).

Registrar Corp assists Cystine Chromatographic companies with:

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