---
kind: "section"
citation: "21 C.F.R. § 864.9600"
title: "21"
number: "864.9600"
heading: "Potentiating media for in vitro diagnostic use."
url: "https://uscodex.org/cfr/21/864.9600"
---

# §864.9600. Potentiating media for in vitro diagnostic use.

- (a) **Identification.** Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]

### Authority

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

### Amendments

[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]