Product code PFT

Device name
Reagents For Molecular Diagnostic Test Systems
Medical specialty
Clinical Chemistry
Device class
1
Regulation number
862.3800
Review panel
TX
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset