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U.S. FDA Medical Device Sterile Specimen Trap Requirements

FDA Medical Device Definition: A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Registrar Corp assists Sterile Specimen Trap companies with:

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