Euro-Diagnostics BV
Country not established
- Devices
- 5
What Euro-Diagnostics BV makes
Euro-Diagnostics BV manufactures in vitro diagnostic reagents for hormone assays, including immunoradiometric assays (IRMA) for luteinizing hormone (LH), follicle-stimulating hormone (FSH), adrenocorticotropic hormone (ACTH), prolactin, and thyroid-stimulating hormone (TSH). These products use radioactive iodine-125 (125I) labeling for detection in clinical laboratory settings.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Blhi Luteinizing Hormone Ref K851332
510(k) 510(k)Irma Immunoradiometric Assay-Fsh 125I Ref K843930
510(k) 510(k)Baci 6 -Adrenocorticotroop Hormone Ref K850053
510(k) 510(k)Prolactin Irma Ref K842478
510(k) 510(k)Tsh Irma(125I) Btsi 1(Thyroid Stimula-Hormone Ref K851148
510(k) 510(k)
Frequently asked questions
How many devices does Euro-Diagnostics BV have in the registry?
The registry currently lists 5 devices for Euro-Diagnostics BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Euro-Diagnostics BV's devices?
Among its 5 most recently registered devices, Euro-Diagnostics BV has devices listed in FDA 510(k) (5 devices).
What risk classes do Euro-Diagnostics BV's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Euro-Diagnostics BV's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Euro-Diagnostics BV in the registry?
The most recently registered devices listed for Euro-Diagnostics BV include BLHI LUTEINIZING HORMONE, IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I, BACI 6 -ADRENOCORTICOTROOP HORMONE and PROLACTIN IRMA.