CFR section
21 CFR 660.31: Eligibility of donor
PART 660-ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS · Subpart D-Reagent Red Blood Cells
Key facts
| Citation | 21 CFR 660.31 |
|---|---|
| Section | Eligibility of donor |
| Part | PART 660-ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS |
| Subpart | Subpart D-Reagent Red Blood Cells |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | Donors of peripheral blood for Reagent Red Blood Cells must meet all the criteria for donor eligibility under §§ 630.10 and 630.15 of this chapter. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.