FDA product code PUQ: Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
PUQ is the FDA product code for multiplex flow immunoassay, t. gondii, rubella, cmv igm. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under PUQ. The average 510(k) review took 87 days (median 87).
Definition
The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.
Classification
| Field | Value |
|---|---|
| Device name | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PUQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
Compare with all 510(k) review times · Search every PUQ clearance
Top PUQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad Laboratories | 1 | 2017-05-19 |
Most recent PUQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170509 | Bio-Rad Laboratories | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | 2017-05-19 | 87 |
Recalls for PUQ devices
openFDA lists no recalls for product code PUQ.
Frequently asked questions
What is FDA product code PUQ?
PUQ is the FDA product code for multiplex flow immunoassay, t. gondii, rubella, cmv igm. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is PUQ?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code PUQ?
Across 1 cleared submissions the average was 87 days from receipt to decision (median 87).
Which companies have the most PUQ clearances?
Bio-Rad Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PUQ
- Run a recall and safety report across every PUQ manufacturer
- Watch product code PUQ 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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