PEG — Nucleic Acid Quantitation Kit Class I
FDA product code PEG covers "Nucleic Acid Quantitation Kit", a Class I medical device regulated under 21 CFR 862.2310. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- PEG
- Device Class
- Class I
- Regulation Number
- 862.2310
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.