FDA product code GQO: Antisera, Cf, Herpesvirus Hominis 1,2
GQO is the FDA product code for antisera, cf, 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 16 510(k) submissions under GQO, from 12 different applicants. The average 510(k) review took 245 days (median 204). FDA has posted 1 recall for GQO devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, 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 GQO clearance
Top GQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electro-Nucleonics, Inc. | 2 | 1989-03-10 |
| Armkel, LLC | 2 | 1987-10-15 |
| Clinical Sciences, Inc. | 2 | 1986-01-21 |
| Amico Lab, Inc. | 2 | 1985-12-06 |
| Bion Ent., Ltd. | 1 | 1988-06-07 |
7 more applicants have GQO clearances. See the full list in Caduvo.
Most recent GQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883281 | Electro-Nucleonics, Inc. | VIRGO HSV-2 IGG ELISA | 1989-03-10 | 219 |
| K883282 | Electro-Nucleonics, Inc. | VIRGO HSV-1 IGG ELISA | 1989-03-10 | 219 |
| K881261 | Bion Ent., Ltd. | BION HSV1-G OR HSV2-G TEST SYSTEM | 1988-06-07 | 75 |
| K875366 | Disease Detection International, Inc. | THE DDI SERODOT HERPES IGG TEST KIT | 1988-05-23 | 144 |
| K871426 | Armkel, LLC | VIROGEN HSV ANTIBODY TEST | 1987-10-15 | 189 |
Recalls for GQO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-01-23.
Frequently asked questions
What is FDA product code GQO?
GQO is the FDA product code for antisera, cf, 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 GQO?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQO?
Across 16 cleared submissions the average was 245 days from receipt to decision (median 204).
Which companies have the most GQO clearances?
Electro-Nucleonics, Inc. (2); Armkel, LLC (2); Clinical Sciences, Inc. (2); Amico Lab, Inc. (2); Bion Ent., Ltd. (1).
Have GQO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-01-23.
Next steps
- Run an FDA pathway report with predicate devices for product code GQO
- Run a recall and safety report across every GQO manufacturer
- Watch product code GQO 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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