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U.S. FDA Medical Device Cytological Preservative Requirements

FDA Medical Device Definition: A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g.,Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA))

Registrar Corp assists Cytological Preservative companies with:

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