Osteometer Biotech A/S
DenmarkFDA applicant, unverified
- Devices
- 2
What Osteometer Biotech A/S makes
Osteometer Biotech A/S manufactures in vitro diagnostic (IVD) immunoassay devices for measuring bone metabolism markers, including the N-MID Osteocalcin One Step ELISA and Serum CrossLaps One Step ELISA. These assays are designed to quantify specific proteins in serum or plasma to assess bone formation and resorption activity.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed via the 510(k) pathway. These assays are intended for laboratory use and are registered with the U.S. Food and Drug Administration.
Catalogue
N-Mid Osteocalcin One Step Elisa Model 30SC4000 Ref K003609
Regimes: 510(k) Registry: 510(k)Serum Crosslaps One Step Elisa Ref K990843
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Osteometer Biotech A/S have in the registry?
The registry currently lists 2 devices for Osteometer Biotech A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteometer Biotech A/S's devices?
Among its 2 most recently registered devices, Osteometer Biotech A/S has devices listed in FDA 510(k) (2 devices).
What risk classes do Osteometer Biotech A/S's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Osteometer Biotech A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osteometer Biotech A/S in the registry?
The most recently registered devices listed for Osteometer Biotech A/S include N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 and SERUM CROSSLAPS ONE STEP ELISA.