Registrar Corp

HomeMedical DevicesRegistration & Medical Device ListingsMedical Device Samples › U.S. FDA Hematocrit Measuring Device Regulations

U.S. FDA Medical Device Hematocrit Measuring Device 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 Measuring Device companies with:

  • FDA Hematocrit Measuring Device Establishment Registration
  • FDA Hematocrit Measuring Device Listing
  • FDA Hematocrit Measuring Device Label Requirements and Exceptions
  • FDA Hematocrit Measuring Device Import Information
  • FDA Hematocrit Measuring Device Detentions (Hematocrit Measuring Device Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Hematocrit Measuring Device Manufacturers (Hematocrit Measuring Device Suppliers)
       - Hematocrit Measuring Device Distributors
       - Hematocrit Measuring Device Processors
       - Hematocrit Measuring Device Repackers
       - Hematocrit Measuring Device Relabelers
       - Hematocrit Measuring Device Exporters
       - Hematocrit Measuring Device Importers
For more information about Hematocrit Measuring Device 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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco