---
kind: "section"
citation: "21 C.F.R. § 801.119"
title: "21"
number: "801.119"
heading: "In vitro diagnostic products."
url: "https://uscodex.org/cfr/21/801.119"
---

# §801.119. In vitro diagnostic products.


A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in [§ 809.3(a)](/cfr/21/809.3.md?p=a) of this chapter shall be deemed to be in compliance with the requirements of this part and [section 502(f)(1)](/cfr/21/502.md?p=f-1) of the Federal Food, Drug, and Cosmetic Act if it meets the requirements of [subpart B](/cfr/21/subpartB.md) of this part and the requirements of [§ 809.10](/cfr/21/809.10.md) of this chapter.


## Notes

### Amendments

[78 FR 58820, Sept. 24, 2013]

### Authority

Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374.

### Source

Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

### Amendments

[78 FR 58820, Sept. 24, 2013]