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.
Registrar Corp assists Nile Blue companies with:
FDA Nile Blue Establishment Registration
FDA Nile Blue Listing
FDA Nile Blue Label Requirements and Exceptions
FDA Nile Blue Import Information
FDA Nile Blue Detentions (Nile Blue Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Nile Blue Manufacturers (Nile Blue Suppliers)
- Nile Blue Distributors
- Nile Blue Processors
- Nile Blue Repackers
- Nile Blue Relabelers
- Nile Blue Exporters
- Nile Blue Importers
For more information about Nile Blue Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.