CFR section
21 CFR 660.33: Testing of source material
PART 660-ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS · Subpart D-Reagent Red Blood Cells
Key facts
| Citation | 21 CFR 660.33 |
|---|---|
| Section | Testing of source material |
| 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, Drugs |
| Regulation text (excerpt) | Except as provided in this section, a sample of each blood incorporated into the Reagent Red Blood Cell product shall be individually tested, with no fewer than two donor sources of each antibody specificity employed, to confirm the identification of all blood group antigens specified in the labeling as present or absent. The manufacturer shall perform at least one of the required tests for each factor. The Reagent Red Blood Cell product may be tested with a single donor source of antibody… |
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