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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Oct 07, 2025
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Title 21
Chapter I
Part 866
Subpart G - 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.
§ 866.6070 - Mutation detection test for myeloproliferative neoplasms.
§ 866.6080 - Next generation sequencing based tumor profiling test.
§ 866.6090 - Cancer predisposition risk assessment system.
§ 866.6100 - DNA-based test to measure minimal residual disease in hematological malignancies.
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