Microphage, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Microphage, Inc. makes
Microphage, Inc. manufactures the KEYPATH MRSA/MSSA Blood Culture Test, a diagnostic device designed to detect methicillin-resistant *Staphylococcus aureus* (MRSA) and methicillin-susceptible *S. aureus* (MSSA) in blood samples.
The company’s portfolio is regulated under Class I devices in the U.S. and includes submissions via FDA’s 510(k) pathway. The devices are listed in the FDA’s 510(k) database.
Catalogue
Keypath Mrsa/Mssa Blood Culture Test-Bt Ref K120563
Regimes: 510(k) Registry: 510(k)Keypath(Tm) Mrsa/Mssa Blood Culture Test- Bt Ref K102342
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Microphage, Inc. have in the registry?
The registry currently lists 2 devices for Microphage, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Microphage, Inc.'s devices?
Among its 2 most recently registered devices, Microphage, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Microphage, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Microphage, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Microphage, Inc. in the registry?
The most recently registered devices listed for Microphage, Inc. include KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT and KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT.