Tumor Associated Antigen immunological Test Systems

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Immunology and Microbiology Devices
  7. Tumor Associated Antigen immunological Test Systems

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Section
866.6010

Tumor-associated antigen immunological test system.

Section
866.6020

Immunomagnetic circulating cancer cell selection and enumeration system.

Section
866.6030

AFP-L3% immunological test system.

Section
866.6040

Gene expression profiling test system for breast cancer prognosis.

Section
866.6050

Ovarian adnexal mass assessment score test system.

Section
866.6060

BCR-ABL quantitation test.

Section
866.6080

Next generation sequencing based tumor profiling test.