FDA product code GNW: Antisera, Cf, Influenza Virus A, B, C
GNW is the FDA product code for antisera, cf, influenza virus a, b, c. It is a Class I device, regulated under 21 CFR 866.3330 and reviewed by the Microbiology panel. FDA has cleared 16 510(k) submissions under GNW, from 8 different applicants. The average 510(k) review took 105 days (median 74). FDA has posted 2 recalls for GNW devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, Influenza Virus A, B, C |
| Device class | Class I |
| Regulation | 21 CFR 866.3330 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNW clearance
Top GNW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Hybrids, Inc. | 5 | 2009-10-21 |
| Dako Diagnostics , Ltd. | 2 | 1997-12-22 |
| Neogenex | 2 | 1994-07-06 |
| Gull Laboratories, Inc. | 2 | 1991-12-17 |
| Sita, Inc. | 2 | 1987-09-18 |
3 more applicants have GNW clearances. See the full list in Caduvo.
Most recent GNW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092882 | Diagnostic Hybrids, Inc. | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | 2009-10-21 | 33 |
| K092300 | Diagnostic Hybrids, Inc. | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | 2009-08-28 | 30 |
| K081746 | Diagnostic Hybrids, Inc. | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | 2008-12-23 | 187 |
| K061101 | Diagnostic Hybrids, Inc. | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | 2006-11-20 | 214 |
| K022713 | Diagnostic Hybrids, Inc. | DFA RESPIRATORY VIRUS SCREENING & ID KIT | 2002-12-18 | 126 |
Recalls for GNW devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-11-24.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0008 — Administration of influenza virus vaccine
- Q2039 — Influenza virus vaccine, not otherwise specified
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu)
Frequently asked questions
What is FDA product code GNW?
GNW is the FDA product code for antisera, cf, influenza virus a, b, c. It is a Class I device, regulated under 21 CFR 866.3330 and reviewed by the Microbiology panel.
What device class is GNW?
Class I, regulation 21 CFR 866.3330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNW?
Across 16 cleared submissions the average was 105 days from receipt to decision (median 74).
Which companies have the most GNW clearances?
Diagnostic Hybrids, Inc. (5); Dako Diagnostics , Ltd. (2); Neogenex (2); Gull Laboratories, Inc. (2); Sita, Inc. (2).
Have GNW devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2008-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GNW
- Run a recall and safety report across every GNW manufacturer
- Watch product code GNW 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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