U.S. FDA Medical Device Anti-Streptokinase Requirements
FDA Medical Device Definition: Streptococcus spp. exoenzyme reagents are devices used to identify antibodies toStreptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.
FDA Anti-Streptokinase Label Requirements and Exceptions
FDA Anti-Streptokinase Import Information
FDA Anti-Streptokinase Detentions (Anti-Streptokinase Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Anti-Streptokinase Manufacturers (Anti-Streptokinase Suppliers)
- Anti-Streptokinase Distributors
- Anti-Streptokinase Processors
- Anti-Streptokinase Repackers
- Anti-Streptokinase Relabelers
- Anti-Streptokinase Exporters
- Anti-Streptokinase Importers
For more information about Anti-Streptokinase 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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