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U.S. FDA Medical Device Cocaine and Cocaine Metabolite Test Requirements: Cocaine and Cocaine Metabolite Test

FDA Medical Device Definition: A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose

Registrar Corp assists Cocaine and Cocaine Metabolite Test companies with:

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




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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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