Nyegaard & Co. A/S
Country not established
- Devices
- 4
What Nyegaard & Co. A/S makes
Nyegaard & Co. A/S manufactures reference materials for laboratory use, including AUTONORM for automated immunoassay systems, PATHONORM H & L for hormone level testing, and SERONORM series products for lipid and general serum parameter measurement. These products serve as calibrated controls to ensure accuracy in diagnostic testing.
The portfolio consists of Class I medical devices, authorised via the FDA’s 510(k) pathway. Products are listed under the FDA’s regulatory framework and the company operates from the United States.
Catalogue
Autonorm Ref K771438
Regimes: 510(k) Registry: 510(k)Pathonorm H & L Ref K771439
Regimes: 510(k) Registry: 510(k)Seronorm Lipid Ref K771437
Regimes: 510(k) Registry: 510(k)Seronorm Ref K771436
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nyegaard & Co. A/S have in the registry?
The registry currently lists 4 devices for Nyegaard & Co. A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nyegaard & Co. A/S's devices?
Among its 4 most recently registered devices, Nyegaard & Co. A/S has devices listed in FDA 510(k) (4 devices).
What risk classes do Nyegaard & Co. A/S's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Nyegaard & Co. A/S's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Nyegaard & Co. A/S in the registry?
The most recently registered devices listed for Nyegaard & Co. A/S include AUTONORM, PATHONORM H & L, SERONORM LIPID and SERONORM.