Antigens, If, Toxoplasma Gondii
The Toxoplasma Gondii Immunofluorescence (IF) Antigen is a microbiology reagent used in the serological diagnosis of toxoplasmosis, a parasitic infection caused by Toxoplasma gondii, through indirect immunofluorescence assay methods. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GLZ, regulated under 21 CFR 866.3780 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- GLZ
- Device Class
- FDA class 2
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924882 | TOXOPLASMA IGM IFA TEST SYSTEM | Mar 23, 1993 | Substantially Equivalent | Zeus Scientific, Inc. |
| K880007 | TOXO IGM TEST | Mar 17, 1988 | Substantially Equivalent | Gull Laboratories, Inc. |
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | Apr 30, 1985 | Substantially Equivalent | Intl. Diagnostic Technology |
| K844287 | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII | Jan 07, 1985 | Substantially Equivalent | Apple Diagnostic Products |
| K842664 | ANTI-TOXOPLASMA GONDII KIT | Aug 28, 1984 | Substantially Equivalent | Amico Lab, Inc. |
| K832900 | IMMUNOENZYME TEST SYS-DETECT-IGM ANTI | Nov 14, 1983 | Substantially Equivalent | Bionetic Laboratory Products |
| K830869 | POLYCHACO INDIRECT IMMUNOFLUORESCENCE | Aug 11, 1983 | Substantially Equivalent | Parasitic Disease Consultants |
| K811562 | TOXOPLASMOSIS TEST KIT | Jul 16, 1981 | Substantially Equivalent | Immuno-Diagnostic Products, Inc. |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Jan 29, 1981 | Substantially Equivalent | Microbiological Research Corp. |
| K801720 | TOXO BIO-BEAD TITRATION KIT | Sep 16, 1980 | Substantially Equivalent | Litton Bionetics |
| K791618 | TORCH BIO-BEAD SCREEN KIT | Nov 13, 1979 | Substantially Equivalent | Litton Bionetics |
| K791611 | TOXO BIO-BEAD SCREEN KIT | Nov 13, 1979 | Substantially Equivalent | Litton Bionetics |
| K791571 | TOXOPLASMA ANTIBODY TEST SYSTEM | Sep 24, 1979 | Substantially Equivalent | Zeus Scientific, Inc. |
| K790464 | FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO | Jun 13, 1979 | Substantially Equivalent | Intl. Diagnostic Technology |
| K790360 | QUANTAZYME TOXOPLASMA | May 22, 1979 | Substantially Equivalent | Bio-Rad |
| K781549 | TOXELISA TEST KIT | Dec 07, 1978 | Substantially Equivalent | Microbiological Assoc. |
| K780352 | IMMUNOZYME TOXOPLASMA ANTIBODY | Jun 28, 1978 | Substantially Equivalent | Millipore Corp. |
| K772243 | TOXO TEST | Dec 22, 1977 | Substantially Equivalent | Gull Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.