Ortho Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
What Ortho Diagnostics, Inc. makes
Ortho Diagnostics, Inc. manufactures diagnostic reagents and controls for blood coagulation testing, including plasma coagulation controls for abnormal samples, chromogenic assays for antithrombin III, and radioimmunoassay (RIA) kits for thyroid hormone measurement. The company also produces blood group substances (P1 and Lewis), pregnancy test tubes, hematology controls, bovine albumin solutions, and microsample blood collection devices. Assessed controls for drug screening are also part of the portfolio.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. Ortho Diagnostics, Inc. is based in the United States.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Ortho Diagnostics, Inc. have in the registry?
The registry currently lists 24 devices for Ortho Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho Diagnostics, Inc.'s devices?
Among its 24 most recently registered devices, Ortho Diagnostics, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Ortho Diagnostics, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Ortho Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortho Diagnostics, Inc. in the registry?
The most recently registered devices listed for Ortho Diagnostics, Inc. include PLASMA COAGULATION CONT., ABNORMAL, P1 BLOOD GROUP SUBSTANCE, ASSAY, CHROMOGENIC ANTITHROMBIN III and ORTHO*T-3 RIA (PEG) KIT.