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U.S. FDA Medical Device Formalin-Containing Fixative 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 Formalin-Containing Fixative companies with:

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






 
Regulaciones U.S. FDA:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


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