Olympus Life Science Research Europa GmbH (Europa)
Country not established
- Devices
- 3
What Olympus Life Science Research Europa GmbH (Europa) makes
The company produces in vitro diagnostic reagents and test systems for clinical laboratory use, including direct bilirubin measurement reagents, alpha-fetoprotein (AFP) assays, and total beta-human chorionic gonadotropin (β-hCG) test kits.
These diagnostic devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Olympus Direct Bilirubin Reagent, Model OSR6X181 Ref K080435
Regimes: 510(k) Registry: 510(k)Olympus Afp - Alpha-Fetoprotein Ref K081709
Regimes: 510(k) Registry: 510(k)Olympus Total Bhcg Test Systen Ref K080094
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Olympus Life Science Research Europa GmbH (Europa) have in the registry?
The registry currently lists 3 devices for Olympus Life Science Research Europa GmbH (Europa). Devices recorded under merged duplicate company entries are counted once.
Which registries list Olympus Life Science Research Europa GmbH (Europa)'s devices?
Among its 3 most recently registered devices, Olympus Life Science Research Europa GmbH (Europa) has devices listed in FDA 510(k) (3 devices).
What risk classes do Olympus Life Science Research Europa GmbH (Europa)'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Olympus Life Science Research Europa GmbH (Europa)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Olympus Life Science Research Europa GmbH (Europa) in the registry?
The most recently registered devices listed for Olympus Life Science Research Europa GmbH (Europa) include OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181, OLYMPUS AFP - ALPHA-FETOPROTEIN and OLYMPUS TOTAL BHCG TEST SYSTEN.