Orgentec
Country not established
- Devices
- 10
What Orgentec makes
Orgentec manufactures in vitro diagnostic assays for detecting specific autoantibodies and proteins, including anti-RNP/SM, anti-SM(Smith), anti-SSA(RO), anti-SSB(La), anti-SCL-70, anti-Jo-1, and anti-dsDNA markers via ELISA and PIN immunoassay formats. Their portfolio also includes assays for detecting anti-ENA antibodies and microalbumin via enzyme immunoassay (EIA).
These diagnostic devices are classified as Class I or Class II under FDA regulations and are recorded in the FDA’s 510(k) clearance database. The company is based in the United States.
Catalogue
Orgentec Anti-Rnp/Sm Pin Immuno Assay Ref K954831
Regimes: 510(k) Registry: 510(k)Orgentec Enascreen Elisa Assay Ref K955134
Regimes: 510(k) Registry: 510(k)Orgentec Anti-Sm(Smith) Pin Immuno Assay Ref K954830
Regimes: 510(k) Registry: 510(k)Orgentec Enascreen Pin Immuno Assay Ref K955133
Regimes: 510(k) Registry: 510(k)Orgen Tec Anti-Dsdna Elisa Assay Ref K953671
Regimes: 510(k) Registry: 510(k)Orgentec Anti-Ss-B(La) Pin Immuno Assay Ref K954832
Regimes: 510(k) Registry: 510(k)Orgentec Anti-Scl 70 Pin Immuno Assay Ref K954814
Regimes: 510(k) Registry: 510(k)Orgentec Anti-Jo-1 Pin Immuno Assay Ref K954829
Regimes: 510(k) Registry: 510(k)Orgentec Micro-Albumin Pin Eia Assay Ref K960274
Regimes: 510(k) Registry: 510(k)Orgentec Anti-Ss-A(Ro) Pin Immuno Assay Ref K954815
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orgentec have in the registry?
The registry currently lists 10 devices for Orgentec. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orgentec's devices?
Among its 10 most recently registered devices, Orgentec has devices listed in FDA 510(k) (10 devices).
What risk classes do Orgentec's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Orgentec's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orgentec in the registry?
The most recently registered devices listed for Orgentec include ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY, ORGENTEC ENASCREEN ELISA ASSAY, ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY and ORGENTEC ENASCREEN PIN IMMUNO ASSAY.