Product code GLZ
- Device name
- Antigens, If, Toxoplasma Gondii
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3780
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924882 | TOXOPLASMA IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | 1993-03-23 |
| K880007 | TOXO IGM TEST | Gull Laboratories, Inc. | 1988-03-17 |
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | Intl. Diagnostic Technology | 1985-04-30 |
| K844287 | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII | Apple Diagnostic Products | 1985-01-07 |
| K842664 | ANTI-TOXOPLASMA GONDII KIT | Amico Lab, Inc. | 1984-08-28 |
| K832900 | IMMUNOENZYME TEST SYS-DETECT-IGM ANTI | Bionetic Laboratory Products | 1983-11-14 |
| K830869 | POLYCHACO INDIRECT IMMUNOFLUORESCENCE | Parasitic Disease Consultants | 1983-08-11 |
| K811562 | TOXOPLASMOSIS TEST KIT | Immuno-Diagnostic Products, Inc. | 1981-07-16 |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Microbiological Research Corp. | 1981-01-29 |
| K801720 | TOXO BIO-BEAD TITRATION KIT | Litton Bionetics | 1980-09-16 |
| K791618 | TORCH BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 |
| K791611 | TOXO BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 |
| K791571 | TOXOPLASMA ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1979-09-24 |
| K790464 | FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO | Intl. Diagnostic Technology | 1979-06-13 |
| K790360 | QUANTAZYME TOXOPLASMA | Bio-Rad | 1979-05-22 |
| K781549 | TOXELISA TEST KIT | Microbiological Assoc. | 1978-12-07 |
| K780352 | IMMUNOZYME TOXOPLASMA ANTIBODY | Millipore Corp. | 1978-06-28 |
| K772243 | TOXO TEST | Gull Laboratories, Inc. | 1977-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G5229020101 | Toxo IgG IFA 120 Test | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G5229020201 | Toxo IgG IFA 204 Test | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G5229020211 | Toxo IgG IFA Slide Only Kit | Hemagen Diagnostics, Inc. | 2023-10-05 |
| 00650551147404 | sEEG DEPTHALON | PMT CORPORATION | 2020-05-07 |
| 00613745010052 | ImmunoFA 10x PBS | GenBio | 2016-09-24 |
| 00613745010069 | ImmunoFA 10x PBS | GenBio | 2016-09-24 |
| 00613745012001 | ImmunoFA Toxoplasma IgG | GenBio | 2016-09-24 |
| 00613745012018 | ImmunoFA Toxoplasma Slides | GenBio | 2016-09-24 |
| 00613745012025 | ImmunoFA Toxoplasma IgG Conjugate | GenBio | 2016-09-24 |
| 00613745012032 | ImmunoFA Toxoplasma IgG Negative Control | GenBio | 2016-09-24 |
| 00613745012049 | ImmunoFA Toxoplasma IgG Low Control | GenBio | 2016-09-24 |
| 00613745012056 | ImmunoFA Toxoplasma IgG High Control | GenBio | 2016-09-24 |
| 00613745012070 | ImmunoFA Toxoplasma Slides | GenBio | 2016-09-24 |
| 00613745013008 | ImmunoFA Toxoplasma IgM | GenBio | 2016-09-24 |
| 00613745013091 | ImmunoFA Toxoplasma IgM Conjugate | GenBio | 2016-09-24 |
| 00613745013411 | ImmunoFA Toxoplasma IgM Positive Control | GenBio | 2016-09-24 |