FDA product code GQW: Antigen, Cf, (Including Cf Control), Varicella-Zoster
GQW is the FDA product code for antigen, cf, (including cf control), varicella-zoster. It is a Class II device, regulated under 21 CFR 866.3900 and reviewed by the Microbiology panel. FDA has cleared 10 510(k) submissions under GQW, from 9 different applicants. The average 510(k) review took 180 days (median 146).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, (Including Cf Control), 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 GQW clearance
Top GQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Viral Antigens, Inc. | 2 | 1997-03-18 |
| Diagnostic Hybrids, Inc. | 1 | 2007-08-30 |
| Light Diagnostics | 1 | 1999-10-19 |
| Viro Research, Inc. | 1 | 1994-12-15 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1991-06-11 |
4 more applicants have GQW clearances. See the full list in Caduvo.
Most recent GQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070206 | Diagnostic Hybrids, Inc. | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | 2007-08-30 | 220 |
| K990141 | Light Diagnostics | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | 1999-10-19 | 273 |
| K964872 | Viral Antigens, Inc. | VZV ANTIGEN CONTROL SLIDES | 1997-03-18 | 103 |
| K942743 | Viro Research, Inc. | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | 1994-12-15 | 188 |
| K912239 | Bd Becton Dickinson Vacutainer Systems Preanalytic | VZVSCAN(TM) LATEX AGGUTINATION TEST | 1991-06-11 | 21 |
Recalls for GQW devices
openFDA lists no recalls for product code GQW.
Frequently asked questions
What is FDA product code GQW?
GQW is the FDA product code for antigen, cf, (including cf control), varicella-zoster. It is a Class II device, regulated under 21 CFR 866.3900 and reviewed by the Microbiology panel.
What device class is GQW?
Class II, regulation 21 CFR 866.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQW?
Across 10 cleared submissions the average was 180 days from receipt to decision (median 146).
Which companies have the most GQW clearances?
Viral Antigens, Inc. (2); Diagnostic Hybrids, Inc. (1); Light Diagnostics (1); Viro Research, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GQW
- Run a recall and safety report across every GQW manufacturer
- Watch product code GQW 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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