PEG

Nucleic Acid Quantitation Kit

Product code

PEG

Device name

Nucleic Acid Quantitation Kit

Device class

Class 1

21 CFR

21 CFR 862.2310

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

FDA classification definition

A nucleic acid quantitation kit consists of a nucleic acid stain (e.g., fluorescent, colorimetric, etc.) which is used to detect and quantitate small amounts of DNA, RNA, or oligonucleotides in solution by measuring the amount of fluorescence or absorbance at a specified wavelength.

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