CYSTICERCOSIS SEROLOGICAL REAGENTS
Device Facts
| Record ID | K900780 |
|---|---|
| Device Name | CYSTICERCOSIS SEROLOGICAL REAGENTS |
| Applicant | Lmd Laboratories |
| Product Code | MDJ · Microbiology |
| Decision Date | Oct 4, 1990 |
| 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.
