FDA product code GSZ: Antigens, Febrile (Weil-Felix), All Groups
GSZ is the FDA product code for antigens, febrile (weil-felix), all groups. It is a Class I device, regulated under 21 CFR 866.3410 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GSZ, from 3 different applicants. The average 510(k) review took 105 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Febrile (Weil-Felix), All Groups |
| Device class | Class I |
| Regulation | 21 CFR 866.3410 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GSZ clearance
Top GSZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Investigacion Farmaceutica S.A. DE C.V. | 1 | 1989-08-15 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1976-11-09 |
| Gamma Biologicals, Inc. | 1 | 1976-08-03 |
Most recent GSZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K885110 | Investigacion Farmaceutica S.A. DE C.V. | PROTEUS OX-19 IFA* | 1989-08-15 | 246 |
| K760881 | Bd Becton Dickinson Vacutainer Systems Preanalytic | FEBRILE ANTIGEN CONTROL SERA | 1976-11-09 | 19 |
| K760097 | Gamma Biologicals, Inc. | FEBRILE ANTIGENS & CONTROL SERUMS | 1976-08-03 | 50 |
Recalls for GSZ devices
openFDA lists no recalls for product code GSZ.
Frequently asked questions
What is FDA product code GSZ?
GSZ is the FDA product code for antigens, febrile (weil-felix), all groups. It is a Class I device, regulated under 21 CFR 866.3410 and reviewed by the Microbiology panel.
What device class is GSZ?
Class I, regulation 21 CFR 866.3410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSZ?
Across 3 cleared submissions the average was 105 days from receipt to decision (median 50).
Which companies have the most GSZ clearances?
Investigacion Farmaceutica S.A. DE C.V. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Gamma Biologicals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GSZ
- Run a recall and safety report across every GSZ manufacturer
- Watch product code GSZ 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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