---
kind: "section"
citation: "21 C.F.R. § 660.30"
title: "21"
number: "660.30"
heading: "Reagent Red Blood Cells."
url: "https://uscodex.org/cfr/21/660.30"
---

# §660.30. Reagent Red Blood Cells.

- (a) **Proper name and definition.** The proper name of the product shall be Reagent Red Blood Cells, which shall consist of a preparation of human red blood cells used to detect or identify human blood-group antibodies.
- (b) **Source.** Reagent Red Blood Cells shall be prepared from human peripheral blood meeting the criteria of §§ [660.31](/cfr/21/660.31.md) and [660.32](/cfr/21/660.32.md) of this chapter, or from umbilical cord cells which shall be collected and prepared according to the manufacturer's biologics license application.

## Notes

### Amendments

[52 FR 37450, Oct. 7, 1987, as amended at 64 FR 56454, Oct. 20, 1999]

### Source

Source: 52 FR 37450, Oct. 7, 1987, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.

### Amendments

[52 FR 37450, Oct. 7, 1987, as amended at 64 FR 56454, Oct. 20, 1999]