Published on: 2022-28035. Final amendment; final order. 2022-28035. Medical Devices; Immunology and Microbiology Devices; Classification of the Human Leukocyte Antigen Typing Companion Diagnostic Test
Published on: 2022-23868. Final amendment; final order. 2022-23868. Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests
Published on: 2022-10461. Final amendment; final order. 2022-10461. Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
Published on: 2022-02368. Final amendment; final order. 2022-02368. Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Microorganisms and Antimicrobial Resistance Using Reporter Expression
Published on: 2022-01156. Proposed rule. 2022-01156. Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests
Published on: 2021-25372. Proposed amendment; proposed order. 2021-25372. Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests
Published on: 2021-25379. Final amendment; final order. 2021-25379. Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests