U.S. FDA Medical Device Alcohol 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)).
FDA Alcohol Containing Fixative Establishment Registration
FDA Alcohol Containing Fixative Listing
FDA Alcohol Containing Fixative Label Requirements and Exceptions
FDA Alcohol Containing Fixative Import Information
FDA Alcohol Containing Fixative Detentions (Alcohol Containing Fixative Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Alcohol Containing Fixative Manufacturers (Alcohol Containing Fixative Suppliers)
- Alcohol Containing Fixative Distributors
- Alcohol Containing Fixative Processors
- Alcohol Containing Fixative Repackers
- Alcohol Containing Fixative Relabelers
- Alcohol Containing Fixative Exporters
- Alcohol Containing 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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