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