---
kind: "section"
citation: "21 C.F.R. § 862.3800"
title: "21"
number: "862.3800"
heading: "Reagents for molecular diagnostic instrument test systems."
url: "https://uscodex.org/cfr/21/862.3800"
---

# §862.3800. Reagents for molecular diagnostic instrument test systems.

- (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](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

[82 FR 61163, Dec. 27, 2017]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[82 FR 61163, Dec. 27, 2017]