Ostex Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Ostex Intl., Inc. makes
Ostex Intl., Inc. manufactures immunoassay kits and point-of-care diagnostic tests for measuring N-terminal telopeptide of type I collagen (NTX), a biomarker for bone resorption. These include serum enzyme immunoassay (EIA) formats and home-use prescription devices designed for clinical and patient monitoring.
The company’s products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearances. Ostex Intl., Inc. is headquartered in the United States.
Catalogue
Osteomark Ntx Serum Eia Ref K983457
Regimes: 510(k) Registry: 510(k)Osteomark(R) Ref K945946
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Osteomark Ref K980518
Regimes: 510(k) Registry: 510(k)Osteomark Ref K961562
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ostex Intl., Inc. have in the registry?
The registry currently lists 5 devices for Ostex Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ostex Intl., Inc.'s devices?
Among its 5 most recently registered devices, Ostex Intl., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Ostex Intl., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Ostex Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ostex Intl., Inc. in the registry?
The most recently registered devices listed for Ostex Intl., Inc. include OSTEOMARK NTX SERUM EIA, OSTEOMARK(R), OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE and OSTEOMARK.