De Novo Classifications
FDA submissions for De Novo Classifications in the Microbiology (MI) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 866.2952–866.4002
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | 866.2952 | 2 | 1 |
| QID | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens | 866.4002 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN200040 | OMNIgene GUT Dx | DNA Genotek, Inc. | Nov 3, 2021 |
| DEN190025 | OraQuick Ebola Rapid Antigen Test | OraSure Technologies, Inc. | Oct 10, 2019 |
