Thermo Fisher Scientific (Life Technologies Holdin
SingaporeFDA applicant, unverified
- Devices
- 1
What Thermo Fisher Scientific (Life Technologies Holdin makes
Thermo Fisher Scientific (Life Technologies Holdings) manufactures real-time polymerase chain reaction (PCR) instruments, including the Applied Biosystems 7500 Fast DX system with SDS software, designed for molecular diagnostics and genetic analysis in clinical and research settings.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Thermo Fisher Scientific (Life Technologies Holdin have in the registry?
The registry currently lists 1 device for Thermo Fisher Scientific (Life Technologies Holdin. Devices recorded under merged duplicate company entries are counted once.
Which registries list Thermo Fisher Scientific (Life Technologies Holdin's devices?
Among its 1 most recently registered device, Thermo Fisher Scientific (Life Technologies Holdin has devices listed in FDA 510(k) (1 device).
What risk classes do Thermo Fisher Scientific (Life Technologies Holdin's devices fall under?
Among its 1 most recently registered device, the classes recorded for Thermo Fisher Scientific (Life Technologies Holdin's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Thermo Fisher Scientific (Life Technologies Holdin in the registry?
The most recently registered devices listed for Thermo Fisher Scientific (Life Technologies Holdin include APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE.