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U.S. Department of Health and Human Services

Product Classification

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Device reagents for molecular diagnostic test systems
Definition Non-analyte-specific reagents used as part of molecular diagnostic test systems, such as polymerases, nucleotides and nucleotide mixes, master mixes in which individual reagents are optimized to be used together.
Physical State Individual reagents or reagent packages
Technical Method Not applicable
Target Area Not applicable
Regulation Medical Specialty Clinical Chemistry
Review Panel Toxicology
Product CodePFT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3800
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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