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U.S. FDA Medical Device Blood Specimen Collection Device Requirements: Blood Specimen Collection Device

FDA Medical Device Definition: A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes

Registrar Corp assists Blood Specimen Collection Device companies with:

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




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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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