Nucleic Acid Quantitation Kit

PEG · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2310

Classification

FDA Product Code: PEG
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 862.2310
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown