FDA product code GQP: Antisera, Neutralization, Parainfluenza Virus 1-4
GQP is the FDA product code for antisera, neutralization, parainfluenza virus 1-4. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GQP, from 2 different applicants. The average 510(k) review took 340 days (median 340).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Neutralization, Parainfluenza Virus 1-4 |
| Device class | Class I |
| Regulation | 21 CFR 866.3400 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GQP clearance
Top GQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dako Diagnostics , Ltd. | 1 | 1998-09-28 |
| Symex Corp. | 1 | 1994-11-28 |
Most recent GQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981226 | Dako Diagnostics , Ltd. | IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 | 1998-09-28 | 188 |
| K933575 | Symex Corp. | VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT | 1994-11-28 | 493 |
Recalls for GQP devices
openFDA lists no recalls for product code GQP.
Frequently asked questions
What is FDA product code GQP?
GQP is the FDA product code for antisera, neutralization, parainfluenza virus 1-4. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel.
What device class is GQP?
Class I, regulation 21 CFR 866.3400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GQP?
Across 2 cleared submissions the average was 340 days from receipt to decision (median 340).
Which companies have the most GQP clearances?
Dako Diagnostics , Ltd. (1); Symex Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GQP
- Run a recall and safety report across every GQP manufacturer
- Watch product code GQP 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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