LHK · Antigen, Id, Candida Albicans
Microbiology · 21 CFR 866.3165 · Class 2
Overview
| Product Code | LHK |
|---|---|
| Device Name | Antigen, Id, Candida Albicans |
| Regulation | 21 CFR 866.3165 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893753 | DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 16, 1989 | SESE |
| K823016 | CANDIDA DETECTION SYSTEM | Ramco Laboratories, Inc. | Dec 28, 1982 | SESE |
| K812741 | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS | Nolan Biological Laboratories, Inc. | Oct 23, 1981 | SESE |
| K812186 | CANDIDA IMMUNODIFFUSION SYSTEM | American Scientific Products | Aug 25, 1981 | SESE |
Top Applicants
- American Scientific Products — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Nolan Biological Laboratories, Inc. — 1 clearance
- Ramco Laboratories, Inc. — 1 clearance
