GMM · Antigens, Iha, Toxoplasma Gondii
Microbiology · 21 CFR 866.3780 · Class 2
Overview
| Product Code | GMM |
|---|---|
| Device Name | Antigens, Iha, Toxoplasma Gondii |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K981263 | TOXOGEN | Instrumentation Laboratory CO | Aug 6, 1998 | SESE |
| K952818 | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | Pyramid Biological Corp. | Nov 20, 1995 | SESE |
| K851977 | HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT | Si Sero-Immuno Diagnostics, Inc. | Oct 16, 1985 | SESE |
| K851976 | HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT | Si Sero-Immuno Diagnostics, Inc. | Oct 16, 1985 | SESE |
| K830870 | POLYCHACO INDIRECT HEMAGGLUTINATION | Parasitic Disease Consultants | Aug 12, 1983 | SESE |
| K802452 | TOXOTEST-MT EIKEN KIT | Syn-Kit, Inc. | Dec 18, 1980 | SESE |
| K790460 | TXOCELL-IHA REAGENT SYSTEM | Calbiochem-Behring Corp. | May 25, 1979 | SESE |
| K771560 | TOXHA TEST | Burroughs Wellcome Co. | Sep 15, 1977 | SESE |
Top Applicants
- Si Sero-Immuno Diagnostics, Inc. — 2 clearances
- Burroughs Wellcome Co. — 1 clearance
- Calbiochem-Behring Corp. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Parasitic Disease Consultants — 1 clearance
