CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
Device Facts
| Record ID | K812188 |
|---|---|
| Device Name | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI |
| Applicant | American Scientific Products |
| Product Code | GMD · Microbiology |
| Decision Date | Aug 31, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3165 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Cryptococcus neoformans serological reagents are devices that consist of antigens used in serological tests to identify antibodies to Cryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identify Cryptococcus neoformans directly from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cryptococcosis and provides epidemiological information on this type of disease. Cryptococcosis infections are found most often as chronic meningitis (inflammation of brain membranes) and, if not treated, are usually fatal.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
