U.S. FDA Medical Device Gelatin-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)).
FDA Gelatin-Formalin Label Requirements and Exceptions
FDA Gelatin-Formalin Import Information
FDA Gelatin-Formalin Detentions (Gelatin-Formalin Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Gelatin-Formalin Manufacturers (Gelatin-Formalin Suppliers)
- Gelatin-Formalin Distributors
- Gelatin-Formalin Processors
- Gelatin-Formalin Repackers
- Gelatin-Formalin Relabelers
- Gelatin-Formalin Exporters
- Gelatin-Formalin Importers
For more information about Gelatin-Formalin Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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