Oncogene Science, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Oncogene Science, Inc. makes
Oncogene Science, Inc. manufactures in vitro diagnostic immunoassay kits for detecting prostate-specific antigen (PSA) and human epidermal growth factor receptor 2 (HER-2/NEU) in serum or plasma samples. These include manual microtiter ELISA formats for total PSA, complexed PSA, and HER-2/NEU testing, designed for laboratory use in oncology diagnostics.
The company’s immunoassay products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database and are intended for use in the United States.
Catalogue
Complexed Psa Microtiter Elisa Ref K002313
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Total Psa Microtiter Elisa Ref K002121
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oncogene Science, Inc. have in the registry?
The registry currently lists 3 devices for Oncogene Science, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oncogene Science, Inc.'s devices?
Among its 3 most recently registered devices, Oncogene Science, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Oncogene Science, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Oncogene Science, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oncogene Science, Inc. in the registry?
The most recently registered devices listed for Oncogene Science, Inc. include COMPLEXED PSA MICROTITER ELISA, MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) and TOTAL PSA MICROTITER ELISA.