FDA product code LTQ: Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
LTQ is the FDA product code for calibrator for alpha-fetoprotein in mid-pregnancy maternal serum. It is a Class III device, reviewed by the Immunology panel. Devices under LTQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LTQ devices
openFDA lists no recalls for product code LTQ.
Frequently asked questions
What is FDA product code LTQ?
LTQ is the FDA product code for calibrator for alpha-fetoprotein in mid-pregnancy maternal serum. It is a Class III device, reviewed by the Immunology panel.
What device class is LTQ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LTQ
- Run a recall and safety report across every LTQ manufacturer
- Watch product code LTQ 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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