U.S. FDA Medical Device Neisseria Controls Requirements
FDA Medical Device Definition: A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
FDA Neisseria Controls Label Requirements and Exceptions
FDA Neisseria Controls Import Information
FDA Neisseria Controls Detentions (Neisseria Controls Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Neisseria Controls Manufacturers (Neisseria Controls Suppliers)
- Neisseria Controls Distributors
- Neisseria Controls Processors
- Neisseria Controls Repackers
- Neisseria Controls Relabelers
- Neisseria Controls Exporters
- Neisseria Controls Importers
For more information about Neisseria Controls 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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