FDA product code GQT: Antisera, Cf, Parainfluenza Virus 1-4
GQT is the FDA product code for antisera, cf, 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 4 510(k) submissions under GQT, from 2 different applicants. The average 510(k) review took 59 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, 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 |
Top GQT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sita, Inc. | 3 | 1987-09-18 |
| Northeast Biomedical Labs., Inc. | 1 | 1978-01-20 |
Most recent GQT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872696 | Sita, Inc. | PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN | 1987-09-18 | 73 |
| K872697 | Sita, Inc. | PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN | 1987-09-18 | 73 |
| K872695 | Sita, Inc. | PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN | 1987-09-18 | 73 |
| K780008 | Northeast Biomedical Labs., Inc. | GOAT ANTI-INFLUENZA ANTISERA | 1978-01-20 | 17 |
Recalls for GQT devices
openFDA lists no recalls for product code GQT.
Frequently asked questions
What is FDA product code GQT?
GQT is the FDA product code for antisera, cf, 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 GQT?
Class I, regulation 21 CFR 866.3400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GQT?
Across 4 cleared submissions the average was 59 days from receipt to decision (median 73).
Which companies have the most GQT clearances?
Sita, Inc. (3); Northeast Biomedical Labs., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GQT
- Run a recall and safety report across every GQT manufacturer
- Watch product code GQT 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.