U.S. FDA Medical Device Richardson Glycol 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)).
FDA Richardson Glycol Fixative Establishment Registration
FDA Richardson Glycol Fixative Listing
FDA Richardson Glycol Fixative Label Requirements and Exceptions
FDA Richardson Glycol Fixative Import Information
FDA Richardson Glycol Fixative Detentions (Richardson Glycol Fixative Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Richardson Glycol Fixative Manufacturers (Richardson Glycol Fixative Suppliers)
- Richardson Glycol Fixative Distributors
- Richardson Glycol Fixative Processors
- Richardson Glycol Fixative Repackers
- Richardson Glycol Fixative Relabelers
- Richardson Glycol Fixative Exporters
- Richardson Glycol Fixative Importers
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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