Applied Biosystems, Inc.
Country not established
- Devices
- 1
What Applied Biosystems, Inc. makes
Applied Biosystems, Inc. manufactures real-time polymerase chain reaction (PCR) systems, such as the Applied Biosystems 7500 Fast DX, designed for nucleic acid amplification and detection in clinical and research settings. These instruments are primarily used for applications like genetic testing, pathogen detection, and molecular diagnostics, enabling high-throughput analysis of DNA and RNA samples.
The company’s portfolio is regulated under Class II medical devices in the United States, with devices authorised through the FDA’s 510(k) clearance process. The products are listed in the FDA’s 510(k) database, adhering to regulatory requirements for performance and safety in molecular diagnostics. The company is headquartered in the United States.
Catalogue
Applied Biosystems 7500 Fast Dx Ref K082562
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Applied Biosystems, Inc. have in the registry?
The registry currently lists 1 device for Applied Biosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Applied Biosystems, Inc.'s devices?
Among its 1 most recently registered device, Applied Biosystems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Applied Biosystems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Applied Biosystems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Applied Biosystems, Inc. in the registry?
The most recently registered devices listed for Applied Biosystems, Inc. include APPLIED BIOSYSTEMS 7500 FAST DX.