FDA product code GNA: Antisera, All Types, Escherichia Coli
GNA is the FDA product code for antisera, 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 12 510(k) submissions under GNA, from 10 different applicants. The average 510(k) review took 183 days (median 152). FDA has posted 1 recall for GNA devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, 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 |
Compare with all 510(k) review times · Search every GNA clearance
Top GNA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 2 | 1995-11-14 |
| Oxoid U.S.A., Inc. | 2 | 1989-02-03 |
| Iverness Medical Professional Diagnostics | 1 | 2007-10-02 |
| Emd Chemicals, Inc. | 1 | 2004-01-23 |
| Oxoid , Ltd. | 1 | 2000-02-28 |
5 more applicants have GNA clearances. See the full list in Caduvo.
Most recent GNA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071799 | Iverness Medical Professional Diagnostics | MODIFICATION TO BIOSTAR OIA SHIGATOX | 2007-10-02 | 92 |
| K031367 | Emd Chemicals, Inc. | DUOPATH VEROTOXINS GLISA TEST | 2004-01-23 | 268 |
| K993401 | Oxoid , Ltd. | DRYSPOT E.COLI 0157 KIT | 2000-02-28 | 143 |
| K981734 | Denka Seiken'S | VTEC-RPLA SEIKEN | 1998-09-22 | 127 |
| K962028 | Murex Diagnostics, Inc. | WELLCOLEX E-COLI OI57 ZC60 | 1996-11-01 | 162 |
Recalls for GNA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-08.
Frequently asked questions
What is FDA product code GNA?
GNA is the FDA product code for antisera, 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 GNA?
Class I, regulation 21 CFR 866.3255. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNA?
Across 12 cleared submissions the average was 183 days from receipt to decision (median 152).
Which companies have the most GNA clearances?
Meridian Diagnostics, Inc. (2); Oxoid U.S.A., Inc. (2); Iverness Medical Professional Diagnostics (1); Emd Chemicals, Inc. (1); Oxoid , Ltd. (1).
Have GNA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-11-08.
Next steps
- Run an FDA pathway report with predicate devices for product code GNA
- Run a recall and safety report across every GNA manufacturer
- Watch product code GNA 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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