PRESS RELEASE: Accelerate Diagnostics Seeks FDA 510(k) Clearance for Expanded Abx Susceptibility Tests
Image created by Dr. Michael J. Miller Accelerate Diagnostics has filed a 510(k) premarket submissio…
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA