Murex Diagnostics Limitd
GermanyFDA applicant, unverified
- Devices
- 1
What Murex Diagnostics Limitd makes
Murex Diagnostics Limited produces the STAPHAUREX PLUS™, a diagnostic test designed for the detection of antibodies to *Staphylococcus aureus* enterotoxin B (SEB) in human serum, plasma, or other biological samples. The test supports serological screening for potential exposure to SEB, commonly used in medical and research settings to assess immune response.
The STAPHAUREX PLUS™ is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Staphaurex Plus(Tm) Ref K945538
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Murex Diagnostics Limitd have in the registry?
The registry currently lists 1 device for Murex Diagnostics Limitd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Murex Diagnostics Limitd's devices?
Among its 1 most recently registered device, Murex Diagnostics Limitd has devices listed in FDA 510(k) (1 device).
What risk classes do Murex Diagnostics Limitd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Murex Diagnostics Limitd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Murex Diagnostics Limitd in the registry?
The most recently registered devices listed for Murex Diagnostics Limitd include STAPHAUREX PLUS(TM).