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U.S. FDA Medical Device Hematocrit Centrifuge Requirements

FDA Medical Device Definition: A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

Registrar Corp assists Hematocrit Centrifuge companies with:

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