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Nucleic Acid Quantitation Kit

Nucleic Acid Quantitation Kit is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Nucleic Acid Quantitation Kit
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PEG

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Class 1

21 CFR 862.2310

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Clinical Chemistry

Device Characteristics

No

No

No

Not 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.