LYF · Pneumocystis Carinii
Microbiology · 21 CFR 866.3780 · Class 2
Overview
| Product Code | LYF |
|---|---|
| Device Name | Pneumocystis Carinii |
| Regulation | 21 CFR 866.3780 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992252 | LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 | Chemicon Intl., Inc. | Aug 10, 1999 | SESE |
| K923349 | FUNGI FLUOR KIT | Polysciences, Inc. | Oct 20, 1992 | SESE |
| K905504 | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII | Dako Corp. | Jun 28, 1991 | SESE |
| K904400 | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION | Meridian Diagnostics, Inc. | Oct 16, 1990 | SESE |
| K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | Genetic Systems Corp. | Mar 21, 1989 | SESE |
| K884047 | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY | Disease Detection International, Inc. | Mar 14, 1989 | SESE |
| K881608 | MERIFLUOR(TM) PNEUMOCYSTIS | Meridian Diagnostics, Inc. | Aug 4, 1988 | SESE |
Top Applicants
- Meridian Diagnostics, Inc. — 2 clearances
- Chemicon Intl., Inc. — 1 clearance
- Dako Corp. — 1 clearance
- Disease Detection International, Inc. — 1 clearance
- Genetic Systems Corp. — 1 clearance
