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U.S. Department of Health and Human Services

Product Classification

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Device nucleic acid quantitation kit
Regulation Description Clinical sample concentrator.
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.
Physical State The device consists of a complete reagent kit or accessory nucleic acid dye reagents intended to be used together.
Technical Method A complete kit or accessory dye reagents which are intended and designed to bind to DNA (single- or double-stranded), RNA, or oligonucleotides depending upon the type of dye utilized. The stained nucleic acid is measured using a spectrophotometer or fluorometer at a specified wavelength.
Target Area Nucleic acids
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePEG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.2310
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Third Party Review Not Third Party Eligible
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