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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.3800

§ 862.3800. Reagents for molecular diagnostic instrument test systems.

84 words·~1 min read·/us/cfr/t21/s§ 862.3800·

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(a)Identification. Reagents for molecular diagnostic test systems are reagents other than 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, and labeled nucleic acid molecules.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedure in subpart E of part 807 of this chapter, subject to the limitations in § 862.9. [82 FR 61163, Dec. 27, 2017]
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§ 862.3800
Reagents for molecular diagnostic instrument test systems.
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