DeviceClearance

Product code PFT— Clinical Chemistry

MISEQDX UNIVERSAL KIT 1.0

Classification name
Reagents For Molecular Diagnostic Test Systems
Device class
Class 1
Regulation
21 CFR 862.3800
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PFT under 21 CFR 862.3800, via openFDA

Market context for product code PFT

FDA has cleared 1 device under product code PFT, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PFT

Recent clearances under product code PFT

Data sourced from openFDA. This site is unofficial and independent of the FDA.