PFT — Reagents For Molecular Diagnostic Test Systems Class I

FDA Device Classification

Classification Details

Product Code
PFT
Device Class
Class I
Regulation Number
862.3800
Submission Type
Review Panel
TX
Medical Specialty
Clinical Chemistry
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN130042illuminaMISEQDX UNIVERSAL KIT 1.0November 19, 2013