Title 21

PART 866 SUBPART G

Subpart G - Tumor Associated Antigen immunological Test Systems

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

21:8.0.1.1.20.7.1.1	SECTION 866.6010	866.6010 Tumor-associated antigen immunological test system.
21:8.0.1.1.20.7.1.2	SECTION 866.6020	866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
21:8.0.1.1.20.7.1.3	SECTION 866.6030	866.6030 AFP-L3% immunological test system.
21:8.0.1.1.20.7.1.4	SECTION 866.6040	866.6040 Gene expression profiling test system for breast cancer prognosis.
21:8.0.1.1.20.7.1.5	SECTION 866.6050	866.6050 Ovarian adnexal mass assessment score test system.
21:8.0.1.1.20.7.1.6	SECTION 866.6060	866.6060 BCR-ABL quantitation test.
21:8.0.1.1.20.7.1.7	SECTION 866.6080	866.6080 Next generation sequencing based tumor profiling test.

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