AGGLUTINOTEST-ECHINOCOCCOSIS
Device Facts
| Record ID | K791451 |
|---|---|
| Device Name | AGGLUTINOTEST-ECHINOCOCCOSIS |
| Applicant | Volu Sol Medical Industries |
| Product Code | GPF · Microbiology |
| Decision Date | Sep 24, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Echinococcus spp. serological reagents are devices that consist of Echinococcus spp. antigens and antisera used in serological tests to identify antibodies to Echinococcus spp. in serum. The identification aids in the diagnosis of echinococcosis, caused by parasitic tapeworms belonging to the genus Echinococcus and provides epidemiological information on this disease. Echinococcosis is characterized by the development of cysts in the liver, lung, kidneys, and other organs formed by the larva of the infecting organisms.
