GLZ · Antigens, If, Toxoplasma Gondii
Microbiology · 21 CFR 866.3780 · Class 2
Overview
| Product Code | GLZ |
|---|---|
| Device Name | Antigens, If, 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924882 | TOXOPLASMA IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | Mar 23, 1993 | SESE |
| K880007 | TOXO IGM TEST | Gull Laboratories, Inc. | Mar 17, 1988 | SESE |
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | Intl. Diagnostic Technology | Apr 30, 1985 | SESE |
| K844287 | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII | Apple Diagnostic Products | Jan 7, 1985 | SESE |
| K842664 | ANTI-TOXOPLASMA GONDII KIT | Amico Lab, Inc. | Aug 28, 1984 | SESE |
| K832900 | IMMUNOENZYME TEST SYS-DETECT-IGM ANTI | Bionetic Laboratory Products | Nov 14, 1983 | SESE |
| K830869 | POLYCHACO INDIRECT IMMUNOFLUORESCENCE | Parasitic Disease Consultants | Aug 11, 1983 | SESE |
| K811562 | TOXOPLASMOSIS TEST KIT | Immuno-Diagnostic Products, Inc. | Jul 16, 1981 | SESE |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Microbiological Research Corp. | Jan 29, 1981 | SESE |
| K801720 | TOXO BIO-BEAD TITRATION KIT | Litton Bionetics | Sep 16, 1980 | SESE |
| K791618 | TORCH BIO-BEAD SCREEN KIT | Litton Bionetics | Nov 13, 1979 | SESE |
| K791611 | TOXO BIO-BEAD SCREEN KIT | Litton Bionetics | Nov 13, 1979 | SESE |
| K791571 | TOXOPLASMA ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | Sep 24, 1979 | SESE |
| K790464 | FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO | Intl. Diagnostic Technology | Jun 13, 1979 | SESE |
| K790360 | QUANTAZYME TOXOPLASMA | Bio-Rad | May 22, 1979 | SESE |
| K781549 | TOXELISA TEST KIT | Microbiological Assoc. | Dec 7, 1978 | SESE |
| K780352 | IMMUNOZYME TOXOPLASMA ANTIBODY | Millipore Corp. | Jun 28, 1978 | SESE |
| K772243 | TOXO TEST | Gull Laboratories, Inc. | Dec 22, 1977 | SESE |
Top Applicants
- Litton Bionetics — 3 clearances
- Gull Laboratories, Inc. — 2 clearances
- Intl. Diagnostic Technology — 2 clearances
- Zeus Scientific, Inc. — 2 clearances
- Amico Lab, Inc. — 1 clearance
