QNCClass II
Whole Exome Sequencing Constituent Device
Medical Genetics · 21 CFR 866.6000
A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
0 adverse event reports on file
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Event type breakdown
No data available.
Most-reported manufacturers
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code