Microbiology Devices: Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices

TitleMicrobiology Devices: Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
ToC Doc Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
Docket Number2024-21932
Type Proposed Rule
Subject Microbiology Devices:
Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
Publication Date2024-09-25
Last Updated Date 2024-09-24 08:21:02 -0400
Last Public Inspection2024-09-24
Filed At2024-09-24T08:45:00.000-04:00
PDF 2024-21932_PI.pdf (190117 bytes)
Download TXT / HTML / JSON
Number of Pages 43
Filing Typeregular
AgenciesFood and Drug Administration

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