FDA product code MAQ: Kit, Dna Detection, Human Papillomavirus
MAQ is the FDA product code for kit, dna detection, human papillomavirus. It is a Class III device, reviewed by the Microbiology panel. Devices under MAQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 8 PMA applications cite this product code. FDA has posted 12 recalls for MAQ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Dna Detection, Human Papillomavirus |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MAQ devices
12 product recalls in 9 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2024 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code MAQ?
MAQ is the FDA product code for kit, dna detection, human papillomavirus. It is a Class III device, reviewed by the Microbiology panel.
What device class is MAQ?
Class III. Typical premarket route: PMA.
Have MAQ devices been recalled?
Yes: 12 product recalls across 9 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MAQ
- Run a recall and safety report across every MAQ manufacturer
- Watch product code MAQ 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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