21 CFR 866.3850 — Antigen, Latex Agglutination, Trichinella Spiralis
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3850
Identification
Trichinella spiralis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trichinella spiralis in serum. The identification aids in the diagnosis of trichinosis caused by parasitic roundworms belonging to the genus Trichinella and provides epidemiological information on trichinosis. Trichinosis is caused by ingestion of undercooked, infested meat, especially pork, and characterized by fever, muscle weakness, and diarrhea.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GPG | Antigen, Latex Agglutination, Trichinella Spiralis | 1 | 2 | |
| GPH | Antiserum, Bentonite Flocculation, Trichinella Spiralis | 1 | 0 | |
| GPI | Antigen, Bentonite Flocculation, Trichinella Spiralis | 1 | 0 | |
| MDT | Elisa, Trichinella Spiralis | 1 | 0 |
