PFT · Class I · 21 CFR 862.3800

FDA Product Code PFT: Reagents For Molecular Diagnostic Test Systems

A Kit That Is A Set Of Reagents And Consumables Used In The Processing Of Human Genomic Dna Samples Derived From Peripheral Whole Blood, And In The Subsequent Targeted Re-sequencing Of The Resulting Sample Libraries. User-supplied Analyte Specific Reagents Are Required For The Preparation Of Libraries Targeting Specific Genomic Regions Of Interest. The Kit Is Intended For Use As Part Of Molecular Diagnostic Test Systems.

Leading manufacturers include Illumina, Inc..

1
Total
0
Cleared
46d
Avg days
2013
Since

FDA 510(k) Cleared Reagents For Molecular Diagnostic Test Systems Devices (Product Code PFT)

1 devices
1–1 of 1
Not Cleared Nov 19, 2013
MISEQDX UNIVERSAL KIT 1.0
DEN130042
Illumina, Inc.
Chemistry · 46d

About Product Code PFT - Regulatory Context