Liofilchem S. R. 1.
ItalyFDA applicant, unverified
- Devices
- 1
What Liofilchem S. R. 1. makes
Liofilchem produces antimicrobial susceptibility test strips, specifically the MTS Lefamulin strip, used to determine bacterial susceptibility to lefamulin within a concentration range of 0.016 to 256 µg/mL. These strips are designed for in vitro diagnostic use in microbiology laboratories to aid in identifying effective antibiotic treatments for bacterial infections.
The company’s products fall under FDA Class II medical devices and are listed via the 510(k) pathway in the United States. The portfolio is regulated under the FDA’s premarket notification process, ensuring compliance with U.S. medical device regulations.
Catalogue
MTS Lefamulin 0.016- 256 µg/mL Ref K200308
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Liofilchem S. R. 1. have in the registry?
The registry currently lists 1 device for Liofilchem S. R. 1.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Liofilchem S. R. 1.'s devices?
Among its 1 most recently registered device, Liofilchem S. R. 1. has devices listed in FDA 510(k) (1 device).
What risk classes do Liofilchem S. R. 1.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Liofilchem S. R. 1.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Liofilchem S. R. 1. in the registry?
The most recently registered devices listed for Liofilchem S. R. 1. include MTS Lefamulin 0.016- 256 µg/mL.