QNC · Class II · 21 CFR 866.6000

FDA Product Code QNC: Whole Exome Sequencing Constituent Device

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.

Leading manufacturers include Helix Opco, LLC.

1
Total
0
Cleared
509d
Avg days
2020
Since

FDA 510(k) Cleared Whole Exome Sequencing Constituent Device Devices (Product Code QNC)

1 devices
1–1 of 1
Not Cleared Dec 23, 2020
Helix Laboratory Platform
DEN190035
Helix Opco, LLC
Medical Genetics · 509d

About Product Code QNC - Regulatory Context