FDA product code GQX: Antiserum, Cf, Varicella-Zoster
GQX is the FDA product code for antiserum, cf, varicella-zoster. It is a Class II device, regulated under 21 CFR 866.3900 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under GQX, from 9 different applicants. The average 510(k) review took 147 days (median 126). FDA has posted 2 recalls for GQX devices.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Cf, Varicella-Zoster |
| Device class | Class II |
| Regulation | 21 CFR 866.3900 |
| 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 GQX clearance
Top GQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gull Laboratories, Inc. | 2 | 1991-07-17 |
| Flow Laboratories, Inc. | 2 | 1977-05-20 |
| Light Diagnostics | 1 | 1996-03-20 |
| Electro-Nucleonics, Inc. | 1 | 1989-03-10 |
| Behring Diagnostics, Inc. | 1 | 1987-04-22 |
4 more applicants have GQX clearances. See the full list in Caduvo.
Most recent GQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951799 | Light Diagnostics | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | 1996-03-20 | 336 |
| K911301 | Gull Laboratories, Inc. | VZV IGM TEST | 1991-07-17 | 114 |
| K883427 | Electro-Nucleonics, Inc. | VIRGO(R) VZV-IGG ELISA | 1989-03-10 | 207 |
| K875358 | Gull Laboratories, Inc. | VZV TEST | 1988-03-31 | 91 |
| K863317 | Behring Diagnostics, Inc. | ENZYGNOST ANTI-VZV IGG TEST | 1987-04-22 | 239 |
Recalls for GQX devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-05-29.
Frequently asked questions
What is FDA product code GQX?
GQX is the FDA product code for antiserum, cf, varicella-zoster. It is a Class II device, regulated under 21 CFR 866.3900 and reviewed by the Microbiology panel.
What device class is GQX?
Class II, regulation 21 CFR 866.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQX?
Across 11 cleared submissions the average was 147 days from receipt to decision (median 126).
Which companies have the most GQX clearances?
Gull Laboratories, Inc. (2); Flow Laboratories, Inc. (2); Light Diagnostics (1); Electro-Nucleonics, Inc. (1); Behring Diagnostics, Inc. (1).
Have GQX devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-05-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GQX
- Run a recall and safety report across every GQX manufacturer
- Watch product code GQX 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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