U.S. FDA Medical Device Complement Reagent Requirements
FDA Medical Device Definition: A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.
FDA Complement Reagent Label Requirements and Exceptions
FDA Complement Reagent Import Information
FDA Complement Reagent Detentions (Complement Reagent Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Complement Reagent Manufacturers (Complement Reagent Suppliers)
- Complement Reagent Distributors
- Complement Reagent Processors
- Complement Reagent Repackers
- Complement Reagent Relabelers
- Complement Reagent Exporters
- Complement Reagent Importers
For more information about Complement Reagent 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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