All regulations
Nonrulemaking
FDA
FDA-2024-N-3533
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Device
Documents
12
Comments
30
Key Dates
Comment Period OpensSep 25, 2024
Comment Period ClosesNov 26, 2024
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Comment Statistics
Total Comments
30
Keywords
2024-18
CDRH
Microbiology Devices
Reclassification of Antigen, Antibody
and Nucleic Acid-Based
Hepatitis B Virus Assay Devices
OPEN
Data from Regulations.gov