FDA Product Code PFF: High Throughput Dna Sequence Analyzer
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.
Leading manufacturers include Illumina, Inc. and Life Technologies Corporation.
2
Total
1
Cleared
100d
Avg days
2013
Since
FDA 510(k) Cleared High Throughput Dna Sequence Analyzer Devices (Product Code PFF)
2 devices
Cleared
Jun 22, 2017
Ion PGM Dx System
Life Technologies Corporation
Chemistry
142d
Not Cleared
Nov 19, 2013
ILLUMINA MISEQDX PLATFORM
Illumina, Inc.
Chemistry
57d