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U.S. Code Regulations Constitution Journal Apps
  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i7
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 866
    PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
  5. subpart G
    Subpart G—Tumor Associated Antigen immunological Test Systems

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.
  • § 866.6080 - Next generation sequencing based tumor profiling test.
  • § 866.6100 - DNA-based test to measure minimal residual disease in hematological malignancies.
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