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510(k) DEN200044

Eonis SCID-SMA Kit by Perkinelmer, Inc. — Product Code QUE

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 9, 2022
Date Received
July 8, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Muscular Atrophy Newborn Screening Test System
Device Class
Class II
Regulation Number
866.5980
Review Panel
MG
Submission Type

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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