Product code PEG

Device name

Nucleic Acid Quantitation Kit

Medical specialty

Clinical Chemistry

Device class

1

Regulation number

862.2310

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset