Regulations.gov document
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To…
Rule · FDA-2024-N-3655 · posted Aug 16, 2024
Key facts
| Document ID | FDA-2024-N-3655-0001 |
|---|---|
| Title | Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS–CoV–2 in Respiratory Specimens |
| Document type | Rule |
| Subtype | Final Rule |
| Agency | FDA |
| Docket | FDA-2024-N-3655 |
| Posted | Aug 16, 2024 |
| Federal Register citation | 89 FR 66552 |
| FR document number | 2024-18266 |
| CFR | 21 CFR Part 866 |
| Effective date | Aug 16, 2024 |
At a glance
- 1–9 Pages
- None Public comments on this docket
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