---
kind: "section"
citation: "21 C.F.R. § 660.20"
title: "21"
number: "660.20"
heading: "Blood Grouping Reagent."
url: "https://uscodex.org/cfr/21/660.20"
---

# §660.20. Blood Grouping Reagent.

- (a) **Proper name and definition.** The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in [§ 660.28(a)(4)](/cfr/21/660.28.md?p=a-4).
- (b) **Source.** The source of this product shall be blood, plasma, serum, or protein-rich fluids, such as those derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.

## Notes

### Amendments

[53 FR 12764, Apr. 19, 1988, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38925, June 15, 2016]

### Source

Source: 53 FR 12764, Apr. 19, 1988, 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

[53 FR 12764, Apr. 19, 1988, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38925, June 15, 2016]