Orion Diagnostica, Inc.
Country not established
- Devices
- 31
What Orion Diagnostica, Inc. makes
Orion Diagnostica, Inc. manufactures in vitro diagnostic tests for infectious disease detection, including rapid antigen tests for respiratory pathogens (e.g., parainfluenza, adenovirus, rotavirus), latex agglutination assays (e.g., *AdenoLex*, *RotaLex 2*), and serological assays for immunoglobulin levels (IgG, IgM) and viral antigens (e.g., *Pyloriset* for *Helicobacter pylori*, *Herpes Simplex Type I*). The portfolio also includes culture pads for bacterial identification (e.g., *RespiCult-STREP*) and controls for viral antigen assays (e.g., *Rubella*, *Varicella-Zoster*).
The company’s diagnostic tests are classified under Class I (general controls) and Class II (special controls) per FDA regulations, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) database, and the company operates from the United States.
Catalogue
Search and filter all 31 devicesFrequently asked questions
How many devices does Orion Diagnostica, Inc. have in the registry?
The registry currently lists 31 devices for Orion Diagnostica, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orion Diagnostica, Inc.'s devices?
Among its 31 most recently registered devices, Orion Diagnostica, Inc. has devices listed in FDA 510(k) (31 devices).
What risk classes do Orion Diagnostica, Inc.'s devices fall under?
Among its 31 most recently registered devices, the classes recorded for Orion Diagnostica, Inc.'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, Inc. in the registry?
The most recently registered devices listed for Orion Diagnostica, Inc. include PYLORISET, RUBELLA VIRUS ANTIGENS & CONTROLS, IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G and QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE.