Elitechgroup Epoch Biosciences
Country not established
- Devices
- 1
What Elitechgroup Epoch Biosciences makes
Elitechgroup Epoch Biosciences manufactures the MRSA/SA ELITE MGB, a molecular diagnostic device for detecting methicillin-resistant *Staphylococcus aureus* (MRSA) and *Staphylococcus aureus* (SA), alongside its associated ELITE MGB software for test analysis and reporting.
The company’s portfolio is regulated under FDA Class II devices, with the MRSA/SA ELITE MGB authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Mrsa/SA Elite Mgb, Elite Mgb Software Ref K132468
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Elitechgroup Epoch Biosciences have in the registry?
The registry currently lists 1 device for Elitechgroup Epoch Biosciences. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elitechgroup Epoch Biosciences's devices?
Among its 1 most recently registered device, Elitechgroup Epoch Biosciences has devices listed in FDA 510(k) (1 device).
What risk classes do Elitechgroup Epoch Biosciences's devices fall under?
Among its 1 most recently registered device, the classes recorded for Elitechgroup Epoch Biosciences's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elitechgroup Epoch Biosciences in the registry?
The most recently registered devices listed for Elitechgroup Epoch Biosciences include MRSA/SA ELITE MGB, ELITE MGB SOFTWARE.