Federal (United States) · Regulations
Subpart G
12 sections
12 sections
- 21 C.F.R. § 866.6000Whole exome sequencing constituent device.
- 21 C.F.R. § 866.6010Tumor-associated antigen immunological test system.
- 21 C.F.R. § 866.6020Immunomagnetic circulating cancer cell selection and enumeration system.
- 21 C.F.R. § 866.6030AFP-L3% immunological test system.
- 21 C.F.R. § 866.6040Gene expression profiling test system for breast cancer prognosis.
- 21 C.F.R. § 866.6050Ovarian adnexal mass assessment score test system.
- 21 C.F.R. § 866.6060BCR-ABL quantitation test.
- 21 C.F.R. § 866.6070Mutation detection test for myeloproliferative neoplasms.
- 21 C.F.R. § 866.6080Next generation sequencing based tumor profiling test.
- 21 C.F.R. § 866.6090Cancer predisposition risk assessment system.
- 21 C.F.R. § 866.6100DNA-based test to measure minimal residual disease in hematological malignancies.
- 21 C.F.R. § 866.6110Circulating tumor cell enrichment device.