§ 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system., Subpart F — Immunological Test Systems, Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES, SUBCHAPTER H — MEDICAL DEVICES, CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, Title 21 - Food and Drugs, Code of Federal Regulations

2020-20716. Proposed amendment; proposed order; request for comments. 2020-20716. Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management
2020-06821. Proposed amendment; proposed order; request for comments. 2020-06821. Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests
2020-06820. Proposed amendment; proposed order; request for comments. 2020-06820. Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
2020-03515. Proposed amendment; proposed order. 2020-03515. Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
2020-01725. Final amendment; final order. 2020-01725. Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology