Orion Diagnostica, Div. Orion Corp.
FinlandFDA applicant, unverified
- Devices
- 4
What Orion Diagnostica, Div. Orion Corp. makes
Orion Diagnostica manufactures in vitro diagnostic devices for detecting C-reactive protein (CRP) and *Helicobacter pylori* infection. Their portfolio includes lateral flow test kits (e.g., QUIKREAD CRP) and enzyme immunoassay (EIA) tests (e.g., PYLORISET EIA-G), as well as dry-format tests for *H. pylori* detection. They also produce ultrasensitive CRP test kits designed for precise clinical measurement.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. These products are intended for laboratory and point-of-care use in the US. Orion Diagnostica operates as a division of Orion Corporation, headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Pyloriset Eia-G (68926) Ref K971537
Regimes: 510(k) Registry: 510(k)Pyloriset Dry Ref K942974
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orion Diagnostica, Div. Orion Corp. have in the registry?
The registry currently lists 4 devices for Orion Diagnostica, Div. Orion Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orion Diagnostica, Div. Orion Corp.'s devices?
Among its 4 most recently registered devices, Orion Diagnostica, Div. Orion Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Orion Diagnostica, Div. Orion Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Orion Diagnostica, Div. Orion Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orion Diagnostica, Div. Orion Corp. in the registry?
The most recently registered devices listed for Orion Diagnostica, Div. Orion Corp. include ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL, PYLORISET EIA-G (68926), PYLORISET DRY and ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257.