§ 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

2020-03515. 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
2019-06026. Final rule. 2019-06026. Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
2019-04719. Final order. 2019-04719. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens
2018-22694. Final order. 2018-22694. Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel