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U.S. FDA Medical Device Specimen Container Requirements

FDA Medical Device Definition: A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

Registrar Corp assists Specimen Container companies with:

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