QJE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Muscular Dystrophy Newborn Screening Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1506
- Medical specialty
- Clinical Chemistry
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| GSP Neonatal Creatine Kinase - MM kit (DEN180056) | Perkinelmer, Inc. | 2019-12-12 |
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