Nordiclab Intl.
Country not established
- Devices
- 8
What Nordiclab Intl. makes
Nordiclab Intl. manufactures radioimmunoassay (RIA) and immunoradiometric assay (IRMA) tests for hormone and biomarker measurement, including progesterone, human placental lactogen (HPL), ferritin, estriol, testosterone, estradiol, and prostatic acid phosphatase.
The company’s assays are classified as Class I or Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for in vitro diagnostic use and are based in the United States.
Catalogue
Nordiclab Progesterone Ria Test Ref K800922
Regimes: 510(k) Registry: 510(k)Ria Test, Nordicalb Hpl Ref K782099
Regimes: 510(k) Registry: 510(k)Nordiclab Ferritin Irma Test Ref K801989
Regimes: 510(k) Registry: 510(k)Nordiclab Total Estriol Ria Test Ref K792189
Regimes: 510(k) Registry: 510(k)Nordiclab Testosterone Ria Test Ref K800921
Regimes: 510(k) Registry: 510(k)Nordiclab Prostatic Acid Phosphatase Ria Ref K801988
Regimes: 510(k) Registry: 510(k)Nordiclab Estradiol Ria Test Ref K800920
Regimes: 510(k) Registry: 510(k)Irma Test, Nordiclab Ferritin Ref K782157
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nordiclab Intl. have in the registry?
The registry currently lists 8 devices for Nordiclab Intl.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nordiclab Intl.'s devices?
Among its 8 most recently registered devices, Nordiclab Intl. has devices listed in FDA 510(k) (8 devices).
What risk classes do Nordiclab Intl.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Nordiclab Intl.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nordiclab Intl. in the registry?
The most recently registered devices listed for Nordiclab Intl. include NORDICLAB PROGESTERONE RIA TEST, RIA TEST, NORDICALB HPL, NORDICLAB FERRITIN IRMA TEST and NORDICLAB TOTAL ESTRIOL RIA TEST.