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U.S. FDA Medical Device Luteinizing Hormone (LH) Test Requirements


FDA Medical Device Definition: A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

Registrar Corp assists Luteinizing Hormone (LH) Test companies with:

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