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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
  7. Subpart G—Tumor Associated Antigen immunological Test Systems

21 CFR Part 866 - Subpart G - Tumor Associated Antigen immunological Test Systems

  • CFR
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  1. § 866.6000 Whole exome sequencing constituent device.
  2. § 866.6010 Tumor-associated antigen immunological test system.
  3. § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
  4. § 866.6030 AFP-L3% immunological test system.
  5. § 866.6040 Gene expression profiling test system for breast cancer prognosis.
  6. § 866.6050 Ovarian adnexal mass assessment score test system.
  7. § 866.6060 BCR-ABL quantitation test.
  8. § 866.6070 Mutation detection test for myeloproliferative neoplasms.
  9. § 866.6080 Next generation sequencing based tumor profiling test.
  10. § 866.6090 Cancer predisposition risk assessment system.
  11. § 866.6100 DNA-based test to measure minimal residual disease in hematological malignancies.

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