Spinal Muscular Atrophy Newborn Screening Test System
- US Product Code (FDA)
- QUEView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.5980View CFR Regulation →
- Medical specialty
- Immunology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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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Spinal Muscular Atrophy Newborn Screening Test System is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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