Centocor, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Centocor, Inc. makes
Centocor, Inc. manufactures radioimmunoassay (RIA) reagents and monoclonal antibodies, including diagnostic kits for measuring tumor markers such as CA 15-3 and CA 125, as well as reagents for rabies antibody testing. Their portfolio also includes collagen-based reagents and controls used in platelet aggregation assays, such as Aggrestat. These products are designed for laboratory use in clinical diagnostics and research settings.
The company’s devices are classified under FDA Class II, requiring premarket notification (510(k)) or a premarket approval (PMA) application for regulatory authorisation. These products are listed in the FDA’s regulatory databases, and the company is headquartered in the United States.
Catalogue
Centocor Ca 15-3 Ria Model No. 800-033 Ref K963803
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Fitc Anti-Rabies Monoclonal Globulin Ref K820499
Regimes: 510(k) Registry: 510(k)Ca 125 Antibody Ria Ref P850009
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Centocor, Inc. have in the registry?
The registry currently lists 4 devices for Centocor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Centocor, Inc.'s devices?
Among its 4 most recently registered devices, Centocor, Inc. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Centocor, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Centocor, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Centocor, Inc. in the registry?
The most recently registered devices listed for Centocor, Inc. include CENTOCOR CA 15-3 RIA MODEL NO. 800-033, CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT, FITC ANTI-RABIES MONOCLONAL GLOBULIN and CA 125 ANTIBODY RIA.