Fujirebio America, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Fujirebio America, Inc. makes
Fujirebio America, Inc. manufactures diagnostic test kits, including the Olympus PK-TP Absorbent Kit for sample collection and the Serodia ATG for detecting specific antibodies in blood samples.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Olympus Pk-Tp Absorbent Kit Ref K905038
510(k) 510(k)Serodia Atg Ref K953066
510(k) 510(k)
Frequently asked questions
How many devices does Fujirebio America, Inc. have in the registry?
The registry currently lists 2 devices for Fujirebio America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fujirebio America, Inc.'s devices?
Among its 2 most recently registered devices, Fujirebio America, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Fujirebio America, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fujirebio America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fujirebio America, Inc. in the registry?
The most recently registered devices listed for Fujirebio America, Inc. include OLYMPUS PK-TP ABSORBENT KIT and SERODIA ATG.