PFT

Reagents For Molecular Diagnostic Test Systems

Product code

PFT

Device name

Reagents For Molecular Diagnostic Test Systems

Device class

Class 1

21 CFR

21 CFR 862.3800

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).