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High Throughput Dna Sequence Analyzer

FDA product code PFF · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 862.2265
Review panel
TX
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-06-22 – 2017-06-22

A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.

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