21 CFR 866.3870 — Antigen, Iha, T. Cruzi
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3870
Identification
Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genus Trypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills, headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion, inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.
Classification Rationale
Class I (general controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GND | Antigen, Iha, T. Cruzi | 1 | 0 | 3rd Party |
| GNE | Antigen, Latex Agglutination, T. Cruzi | 1 | 1 | 3rd Party |
| GNF | Antigen, Cf, T. Cruzi | 1 | 0 | 3rd Party |
| LOO | Reagent, Leishmanii Serological | 1 | 2 | 3rd Party |
| MIU | Enzyme Linked Immunosorbent Assay, T. Cruzi | 1 | 6 | 3rd Party |
| MIV | Immunofluorescent Assay, T. Cruzi | 1 | 0 | 3rd Party |
| OUZ | Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids | 1 | 1 | |
| PIT | Leishmania Spp. Antigen Detection Assay | 1 | 1 | 3rd Party |
