CFR section
21 CFR 809.10(b)(10): Labeling for in vitro diagnostic products
PART 809-IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE · Subpart B-Labeling
Key facts
| Citation | 21 CFR 809.10(b)(10) |
|---|---|
| Section | Labeling for in vitro diagnostic products |
| Part | PART 809-IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE |
| Subpart | Subpart B-Labeling |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (10) Limitation of the procedure: Include a statement of limitations of the procedure. State known extrinsic factors or interfering substances affecting results. If further testing, either more specific or more sensitive, is indicated in all cases where certain results are obtained, the need for the additional test shall be stated. |
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