FDA product code GMS: Anti-Human Globulin, Fta-Abs Test
GMS is the FDA product code for anti-human globulin, fta-abs test. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GMS, from 2 different applicants. The average 510(k) review took 38 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Anti-Human Globulin, Fta-Abs Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| 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 GMS clearance
Top GMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno-Products Industries | 2 | 1985-09-19 |
| Zeus Scientific, Inc. | 1 | 1978-08-21 |
Most recent GMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853122 | Immuno-Products Industries | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | 1985-09-19 | 56 |
| K843613 | Immuno-Products Industries | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | 1984-10-31 | 51 |
| K781403 | Zeus Scientific, Inc. | FTA-ABS TEST SYSTEM | 1978-08-21 | 6 |
Recalls for GMS devices
openFDA lists no recalls for product code GMS.
Frequently asked questions
What is FDA product code GMS?
GMS is the FDA product code for anti-human globulin, fta-abs test. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel.
What device class is GMS?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
How long does a 510(k) take for product code GMS?
Across 3 cleared submissions the average was 38 days from receipt to decision (median 51).
Which companies have the most GMS clearances?
Immuno-Products Industries (2); Zeus Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMS
- Run a recall and safety report across every GMS manufacturer
- Watch product code GMS 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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