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U.S. FDA Medical Device Aldolase Test System Requirements

FDA Medical Device Definition: An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.

Registrar Corp assists Aldolase Test System companies with:

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