Ortho Diagnostic Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 126
What Ortho Diagnostic Systems, Inc. makes
Ortho Diagnostic Systems, Inc. manufactures in vitro diagnostic reagents and controls for coagulation testing, including APTT reagents (e.g., SYNTHASIL, SYNTHAFAX), plasminogen assays (e.g., ORTHOKROME*), and antibody detection kits for Epstein-Barr virus (e.g., EBV VCA-IGG ELISA, Epstein-Barr virus EA(D+R)-IGG). The company also produces pregnancy testing reagents (e.g., ORTHO RESULT PLUS/PREGNANCY) and controls for protein C assays (e.g., ORTHO ABNORMAL PROTEIN C CONTROL PLASMA), as well as coagulation system components (e.g., KOAGULAB* M). Additional products include enzyme immunoassays (e.g., ORTHO*PAP-IA) and spectrum-based diagnostic controls (e.g., ORTHO SPECTRUM III).
The portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for laboratory use in the US, where the manufacturer is based.
Catalogue
Search and filter all 126 devicesShowing 1-50 of 126
Frequently asked questions
How many devices does Ortho Diagnostic Systems, Inc. have in the registry?
The registry currently lists 126 devices for Ortho Diagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho Diagnostic Systems, Inc.'s devices?
Among its 50 most recently registered devices, Ortho Diagnostic Systems, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Ortho Diagnostic Systems, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ortho Diagnostic Systems, 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 Diagnostic Systems, Inc. in the registry?
The most recently registered devices listed for Ortho Diagnostic Systems, Inc. include ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO, SYNTHASIL APTT REAGENT, ORTHO RESULT PLUS/PREGNANCY and ORTHOKROME* PLASMINOGEN.