FDA Medical Device Definition: Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
FDA Giemsa Stain Label Requirements and Exceptions
FDA Giemsa Stain Import Information
FDA Giemsa Stain Detentions (Giemsa Stain Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Giemsa Stain Manufacturers (Giemsa Stain Suppliers)
- Giemsa Stain Distributors
- Giemsa Stain Processors
- Giemsa Stain Repackers
- Giemsa Stain Relabelers
- Giemsa Stain Exporters
- Giemsa Stain Importers
For more information about Giemsa Stain 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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