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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 866 - Immunology and Microbiology Devices |
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Subpart G - Tumor Associated Antigen immunological Test Systems |
| § 866.6000 - Whole exome sequencing constituent device. |
| § 866.6010 - Tumor-associated antigen immunological test system. |
| § 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system. |
| § 866.6030 - AFP-L3% immunological test system. |
| § 866.6040 - Gene expression profiling test system for breast cancer prognosis. |
| § 866.6050 - Ovarian adnexal mass assessment score test system. |
| § 866.6060 - BCR-ABL quantitation test. |
| § 866.6080 - Next generation sequencing based tumor profiling test. |