ON THE SPOT CANDIDASURE
Device Facts
| Record ID | K883118 |
|---|---|
| Device Name | ON THE SPOT CANDIDASURE |
| Applicant | Medi-Tech, Inc. |
| Product Code | LRF · Microbiology |
| Decision Date | Sep 30, 1988 |
| 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.
