FDA product code QJE: Muscular Dystrophy Newborn Screening Test
QJE is the FDA product code for muscular dystrophy newborn screening test. It is a Class II device, regulated under 21 CFR 862.1506 and reviewed by the Clinical Chemistry panel. Devices under QJE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.
Classification
| Field | Value |
|---|---|
| Device name | Muscular Dystrophy Newborn Screening Test |
| Device class | Class II |
| Regulation | 21 CFR 862.1506 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for QJE devices
openFDA lists no recalls for product code QJE.
Frequently asked questions
What is FDA product code QJE?
QJE is the FDA product code for muscular dystrophy newborn screening test. It is a Class II device, regulated under 21 CFR 862.1506 and reviewed by the Clinical Chemistry panel.
What device class is QJE?
Class II, regulation 21 CFR 862.1506. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QJE
- Run a recall and safety report across every QJE manufacturer
- Watch product code QJE 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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