Nucleic Acid Quantitation Kit

Device Code: 655

Product Code(s): PEG

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 Abso

Device Classification Information

• Device Type ID: 655
• Device Name: Nucleic Acid Quantitation Kit
• 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
• Target Area: Nucleic Acids
• Regulation Description: Clinical Sample Concentrator.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.2310 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: PEG
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 655
• Device: Nucleic Acid Quantitation Kit
• Product Code: PEG
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Clinical Sample Concentrator.
• CFR Regulation Number: 862.2310 [🔎]

TPLC Last Update: 2019-04-02 19:38:10