CFR section
21 CFR 1271.80(d)(2): What are the general requirements for donor testing?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.80(d)(2) |
|---|---|
| Section | What are the general requirements for donor testing? |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart C-Donor Eligibility |
| Subchapter | 21 CFR L Other |
| Product types cited | Other_Regulations |
| Regulation text (excerpt) | (2) (i) A donor in whom plasma dilution sufficient to affect the results of communicable disease testing is suspected, unless: (A) You test a specimen taken from the donor before transfusion or infusion and up to 7 days before recovery of cells or tissue; or (B) You use an appropriate algorithm designed to evaluate volumes administered in the 48 hours before specimen collection, and the algorithm shows that plasma dilution sufficient to affect the results of communicable disease testing has not… |
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