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U.S. FDA Medical Device General Purpose Reagent 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 General Purpose Reagent companies with:

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