Olympus Diagnostica GmbH
Country not established
- Devices
- 4
What Olympus Diagnostica GmbH makes
Olympus Diagnostica GmbH produces in vitro diagnostic reagents for clinical chemistry, including creatine kinase, calcium, myoglobin, and serum protein assays. These reagents are designed for use in automated laboratory analyzers to measure specific biomarkers in patient samples, supporting diagnostic and monitoring applications.
The company’s portfolio is regulated as Class II medical devices in the U.S., with relevant products listed under the FDA’s 510(k) pathway. These reagents are intended for in vitro diagnostic use and comply with applicable regulatory requirements for their designated classifications.
Catalogue
Olympus Creatine Kinase Reagent OSR6179/6279 Ref K994189
Regimes: 510(k) Registry: 510(k)Olympus Calcium Arsenazo Iii Reagent Ref K982035
Regimes: 510(k) Registry: 510(k)Olympus Myoglobin Immunoturbidmetric Reagent Ref K984145
Regimes: 510(k) Registry: 510(k)Olympus Serum Protein Multicalibrator, Ref K981854
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Olympus Diagnostica GmbH have in the registry?
The registry currently lists 4 devices for Olympus Diagnostica GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Olympus Diagnostica GmbH's devices?
Among its 4 most recently registered devices, Olympus Diagnostica GmbH has devices listed in FDA 510(k) (4 devices).
What risk classes do Olympus Diagnostica GmbH's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Olympus Diagnostica GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Olympus Diagnostica GmbH in the registry?
The most recently registered devices listed for Olympus Diagnostica GmbH include OLYMPUS CREATINE KINASE REAGENT OSR6179/6279, OLYMPUS CALCIUM ARSENAZO III REAGENT, OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT and OLYMPUS SERUM PROTEIN MULTICALIBRATOR,.