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U.S. FDA Medical Device Neutral Buffered Formalin 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 Neutral Buffered Formalin companies with:

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