FDA product code GQN: Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
GQN is the FDA product code for antigen, cf (including cf control), herpesvirus hominis 1,2. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel. FDA has cleared 34 510(k) submissions under GQN, from 22 different applicants. The average 510(k) review took 162 days (median 118).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 |
| Device class | Class II |
| Regulation | 21 CFR 866.3305 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GQN clearance
Top GQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Hybrids, Inc. | 7 | 2007-10-24 |
| Viral Antigens, Inc. | 2 | 1997-07-01 |
| Enzo Biochem, Inc. | 2 | 1988-08-03 |
| Whittaker Bioproducts, Inc. | 2 | 1988-05-13 |
| Syva Co. | 2 | 1988-02-18 |
17 more applicants have GQN clearances. See the full list in Caduvo.
Most recent GQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070265 | Diagnostic Hybrids, Inc. | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 | 2007-10-24 | 268 |
| K063798 | Diagnostic Hybrids, Inc. | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 | 2007-09-21 | 273 |
| K991880 | Light Diagnostics | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | 1999-11-09 | 160 |
| K971662 | Diagnostic Hybrids, Inc. | ELVIS HSV ID/TYPING TEST SYSTEM | 1997-11-18 | 203 |
| K964874 | Viral Antigens, Inc. | HSV-1 ANTIGEN CONTROL SLIDES | 1997-07-01 | 208 |
Recalls for GQN devices
openFDA lists no recalls for product code GQN.
Frequently asked questions
What is FDA product code GQN?
GQN is the FDA product code for antigen, cf (including cf control), herpesvirus hominis 1,2. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel.
What device class is GQN?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQN?
Across 34 cleared submissions the average was 162 days from receipt to decision (median 118).
Which companies have the most GQN clearances?
Diagnostic Hybrids, Inc. (7); Viral Antigens, Inc. (2); Enzo Biochem, Inc. (2); Whittaker Bioproducts, Inc. (2); Syva Co. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GQN
- Run a recall and safety report across every GQN manufacturer
- Watch product code GQN 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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