Agen Biomedical, Ltd.
Country not established
- Devices
- 6
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Simplify D-Dimer, Model DCGK1 Ref K993276
Regimes: 510(k) Registry: 510(k)Bed Red D-Dimer Whole Blood Agglutination Assay Ref K905643
Regimes: 510(k) Registry: 510(k)Dimertest Latex Assay Ref K974596
Regimes: 510(k) Registry: 510(k)Agen Dimertest Eia Ref K890189
Regimes: 510(k) Registry: 510(k)Agen Dimertest Gold Eia Ref K945642
Regimes: 510(k) Registry: 510(k)Dimertest(R) Latex Ref K882944
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Agen Biomedical, Ltd. have in the registry?
The registry currently lists 6 devices for Agen Biomedical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Agen Biomedical, Ltd.'s devices?
Among its 6 most recently registered devices, Agen Biomedical, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Agen Biomedical, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Agen Biomedical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Agen Biomedical, Ltd. in the registry?
The most recently registered devices listed for Agen Biomedical, Ltd. include SIMPLIFY D-DIMER, MODEL DCGK1, BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY, DIMERTEST LATEX ASSAY and AGEN DIMERTEST EIA.