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PEGClass I

Nucleic Acid Quantitation Kit

21 CFR 862.2310 / Clinical Chemistry
FDA source (opens on fda.gov)

PEG is the FDA product code for Nucleic Acid Quantitation Kit, a class I device type, regulated under 21 CFR 862.2310. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PEG
Device name
Nucleic Acid Quantitation Kit
FDA 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.
Regulation
21 CFR 862.2310
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code