Novo Nordisk Diagnostics, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 2
What Novo Nordisk Diagnostics, Ltd. makes
Novo Nordisk Diagnostics, Ltd. manufactures diagnostic tests for chlamydia detection, including the IDEIA™ Chlamydia assay and its modified version. These products are designed for laboratory use to identify chlamydia trachomatis infections through immunoassay technology.
The company’s diagnostic tests fall under FDA device classes I and II, with regulatory submissions recorded in the FDA’s 510(k) clearance database. The portfolio is listed under the US jurisdiction, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Ideia(Tm) Chlamydia, Modification Ref K911430
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Novo Nordisk Diagnostics, Ltd. have in the registry?
The registry currently lists 2 devices for Novo Nordisk Diagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novo Nordisk Diagnostics, Ltd.'s devices?
Among its 2 most recently registered devices, Novo Nordisk Diagnostics, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Novo Nordisk Diagnostics, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Novo Nordisk Diagnostics, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Novo Nordisk Diagnostics, Ltd. in the registry?
The most recently registered devices listed for Novo Nordisk Diagnostics, Ltd. include ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA and IDEIA(TM) CHLAMYDIA, MODIFICATION.