QUE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Spinal Muscular Atrophy Newborn Screening Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5980
- Medical specialty
- Immunology
- FDA definition
- A Spinal Muscular Atrophy (SMA) newborn screening test system is a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction-based test as an aid in screening newborns for SMA. Presumptive positive results are intended to be followed up by diagnostic confirmatory testing.
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| Record | Firm | Date |
|---|---|---|
| Eonis SCID-SMA Kit (DEN200044) | Perkinelmer, Inc. | 2022-11-09 |
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