PFT · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.3800
Classification
FDA Product Code
PFT
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.3800
Review panel
TX
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.