FDA product code GMZ: Antigens, All Types, Escherichia Coli
GMZ is the FDA product code for antigens, all types, escherichia coli. It is a Class I device, regulated under 21 CFR 866.3255 and reviewed by the Microbiology panel. FDA has cleared 14 510(k) submissions under GMZ, 1 in the last five years, from 11 different applicants. The average 510(k) review took 167 days (median 146). FDA has posted 2 recalls for GMZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, All Types, Escherichia Coli |
| Device class | Class I |
| Regulation | 21 CFR 866.3255 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for GMZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 210 |
Compare with all 510(k) review times · Search every GMZ clearance
Top GMZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 3 | 2023-04-17 |
| Techlab Inc., Corporate Research Center | 2 | 2012-10-02 |
| Inverness Medical-Biostar, Inc. | 1 | 2006-12-12 |
| Meridian Diagnostics, Inc. | 1 | 1999-08-09 |
| Alexon - Trend, Inc. | 1 | 1998-04-23 |
6 more applicants have GMZ clearances. See the full list in Caduvo.
Most recent GMZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222829 | Meridian Bioscience, Inc. | Curian® Shiga Toxin | 2023-04-17 | 210 |
| K121364 | Techlab Inc., Corporate Research Center | SHIGA TOXIN QUIK CHEK | 2012-10-02 | 148 |
| K121411 | Techlab Inc., Corporate Research Center | SHIGA TOXIN CHEK | 2012-10-02 | 144 |
| K062546 | Meridian Bioscience, Inc. | IMMUNOCARD STAT! EHEC, MODEL 751630 | 2007-02-14 | 168 |
| K061889 | Inverness Medical-Biostar, Inc. | BIOSTAR OIA SHIGATOX | 2006-12-12 | 162 |
Recalls for GMZ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-08-21.
Frequently asked questions
What is FDA product code GMZ?
GMZ is the FDA product code for antigens, all types, escherichia coli. It is a Class I device, regulated under 21 CFR 866.3255 and reviewed by the Microbiology panel.
What device class is GMZ?
Class I, regulation 21 CFR 866.3255. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMZ?
Across 14 cleared submissions the average was 167 days from receipt to decision (median 146).
Which companies have the most GMZ clearances?
Meridian Bioscience, Inc. (3); Techlab Inc., Corporate Research Center (2); Inverness Medical-Biostar, Inc. (1); Meridian Diagnostics, Inc. (1); Alexon - Trend, Inc. (1).
Have GMZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2006-08-21.
Next steps
- Run an FDA pathway report with predicate devices for product code GMZ
- Run a recall and safety report across every GMZ manufacturer
- Watch product code GMZ 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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