FDA Medical Device Definition: Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.
FDA Giardia Spp. Label Requirements and Exceptions
FDA Giardia Spp. Import Information
FDA Giardia Spp. Detentions (Giardia Spp. Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Giardia Spp. Manufacturers (Giardia Spp. Suppliers)
- Giardia Spp. Distributors
- Giardia Spp. Processors
- Giardia Spp. Repackers
- Giardia Spp. Relabelers
- Giardia Spp. Exporters
- Giardia Spp. Importers
For more information about Giardia Spp. 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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