FDA product code GQL: Antisera, Fluorescent, Herpesvirus Hominis 1,2
GQL is the FDA product code for antisera, fluorescent, 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 37 510(k) submissions under GQL, from 23 different applicants. The average 510(k) review took 123 days (median 94).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, 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 GQL clearance
Top GQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 5 | 1999-05-26 |
| Syva Co. | 4 | 1985-03-11 |
| Immulok, Inc. | 4 | 1983-06-30 |
| Ortho Diagnostic Systems, Inc. | 3 | 1989-06-06 |
| Baxter Healthcare Corp | 2 | 1990-07-31 |
18 more applicants have GQL clearances. See the full list in Caduvo.
Most recent GQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091753 | Diagnostic Hybrids, Inc. | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | 2009-08-28 | 73 |
| K081527 | Millipore Corporation | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | 2009-04-01 | 303 |
| K984120 | Zeus Scientific, Inc. | THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | 1999-05-26 | 189 |
| K984135 | Zeus Scientific, Inc. | THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | 1999-05-26 | 189 |
| K905608 | Stellar Bio Systems, Inc. | INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 | 1991-11-07 | 328 |
Recalls for GQL devices
openFDA lists no recalls for product code GQL.
Frequently asked questions
What is FDA product code GQL?
GQL is the FDA product code for antisera, fluorescent, 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 GQL?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code GQL?
Across 37 cleared submissions the average was 123 days from receipt to decision (median 94).
Which companies have the most GQL clearances?
Zeus Scientific, Inc. (5); Syva Co. (4); Immulok, Inc. (4); Ortho Diagnostic Systems, Inc. (3); Baxter Healthcare Corp (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GQL
- Run a recall and safety report across every GQL manufacturer
- Watch product code GQL 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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