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U.S. FDA Medical Device Isotonic Solution 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 Isotonic Solution companies with:

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