FDA product code GNB: Antisera, All Types, Shigella Spp.
GNB is the FDA product code for antisera, all types, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel. FDA has cleared 41 510(k) submissions under GNB, from 4 different applicants. The average 510(k) review took 36 days (median 28). FDA has posted 3 recalls for GNB devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Types, Shigella Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNB clearance
Top GNB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sa Scientific, Inc. | 38 | 1996-05-31 |
| Wellcome Diagnostics | 1 | 1990-01-11 |
| Pharmacia, Inc. | 1 | 1989-02-17 |
| Analytical Products, Inc. | 1 | 1982-05-28 |
Most recent GNB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961537 | Sa Scientific, Inc. | SAS SHIGELLA SONNEI FORM II ANTISERUM | 1996-05-31 | 39 |
| K961549 | Sa Scientific, Inc. | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | 1996-05-20 | 28 |
| K961548 | Sa Scientific, Inc. | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | 1996-05-20 | 28 |
| K961538 | Sa Scientific, Inc. | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | 1996-05-20 | 28 |
| K961533 | Sa Scientific, Inc. | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | 1996-05-20 | 28 |
Recalls for GNB devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code GNB?
GNB is the FDA product code for antisera, all types, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel.
What device class is GNB?
Class II, regulation 21 CFR 866.3660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNB?
Across 41 cleared submissions the average was 36 days from receipt to decision (median 28).
Which companies have the most GNB clearances?
Sa Scientific, Inc. (38); Wellcome Diagnostics (1); Pharmacia, Inc. (1); Analytical Products, Inc. (1).
Have GNB devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2017-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code GNB
- Run a recall and safety report across every GNB manufacturer
- Watch product code GNB 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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