Regulation
FDA Class II Classification: Nucleic Acid Detection System for STIs Using Home-Collected Specimens (2026)
FollowFollow- Full name
- Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
- Citation
- 91 FR 64611
- Jurisdiction
- U.S.
- In force
- 2026-10-09
- Text
- federalregister.gov/documents/2026/10/09/2026-20727/medical-devices-immunology-and-microbiology-devices-classification-of-the-system-for-detection-of
- Stories
- 1
Medical devicesHealthcare