GMD · Antisera, Latex Agglutination, Cryptococcus Neoformans
Microbiology · 21 CFR 866.3165 · Class 2
Overview
| Product Code | GMD |
|---|---|
| Device Name | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | Immuno-Mycologics, Inc. | Mar 28, 2012 | SESE |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | Immuno-Mycologics, Inc. | Jul 20, 2011 | SESE |
| K930418 | CRYPTO-LEX SYSTEM | Trinity Laboratories, Inc. | Feb 17, 1994 | SESE |
| K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | Alexon Biomedical, Inc. | Nov 22, 1993 | SESE |
| K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | Meridian Diagnostics, Inc. | Sep 8, 1989 | SESE |
| K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI | American Scientific Products | Aug 31, 1981 | SESE |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | Immuno-Mycologics, Inc. | Mar 20, 1981 | SESE |
| K792693 | CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX | Meridian Diagnostics, Inc. | Jan 21, 1980 | SESE |
| K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM | I M, Inc. | Apr 28, 1978 | SESE |
Top Applicants
- Immuno-Mycologics, Inc. — 4 clearances
- Meridian Diagnostics, Inc. — 2 clearances
- Alexon Biomedical, Inc. — 1 clearance
- American Scientific Products — 1 clearance
- I M, Inc. — 1 clearance
