FDA product code GLZ: Antigens, If, Toxoplasma Gondii
GLZ is the FDA product code for antigens, if, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under GLZ, from 13 different applicants. The average 510(k) review took 79 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, If, Toxoplasma Gondii |
| Device class | Class II |
| Regulation | 21 CFR 866.3780 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GLZ clearance
Top GLZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Litton Bionetics | 3 | 1980-09-16 |
| Zeus Scientific, Inc. | 2 | 1993-03-23 |
| Gull Laboratories, Inc. | 2 | 1988-03-17 |
| Intl. Diagnostic Technology | 2 | 1985-04-30 |
| Apple Diagnostic Products | 1 | 1985-01-07 |
8 more applicants have GLZ clearances. See the full list in Caduvo.
Most recent GLZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924882 | Zeus Scientific, Inc. | TOXOPLASMA IGM IFA TEST SYSTEM | 1993-03-23 | 176 |
| K880007 | Gull Laboratories, Inc. | TOXO IGM TEST | 1988-03-17 | 73 |
| K850591 | Intl. Diagnostic Technology | FIAX TOXO-M ANTIBODIES TEST KIT | 1985-04-30 | 75 |
| K844287 | Apple Diagnostic Products | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII | 1985-01-07 | 63 |
| K842664 | Amico Lab, Inc. | ANTI-TOXOPLASMA GONDII KIT | 1984-08-28 | 49 |
Recalls for GLZ devices
openFDA lists no recalls for product code GLZ.
Frequently asked questions
What is FDA product code GLZ?
GLZ is the FDA product code for antigens, if, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel.
What device class is GLZ?
Class II, regulation 21 CFR 866.3780. Typical premarket route: 510(k).
How long does a 510(k) take for product code GLZ?
Across 18 cleared submissions the average was 79 days from receipt to decision (median 76).
Which companies have the most GLZ clearances?
Litton Bionetics (3); Zeus Scientific, Inc. (2); Gull Laboratories, Inc. (2); Intl. Diagnostic Technology (2); Apple Diagnostic Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GLZ
- Run a recall and safety report across every GLZ manufacturer
- Watch product code GLZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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