Pan Bio Pty., Ltd.
AustraliaFDA applicant, unverified
- Devices
- 4
What Pan Bio Pty., Ltd. makes
Pan Bio Pty. , Ltd. manufactures enzyme-linked immunosorbent assay (ELISA) kits designed for the detection of Epstein-Barr virus (EBV) antibodies. Their product line includes specific diagnostic test kits for EBV VCA IgM, EBV EA-D IgG, EBV-EBNA IgG, and EBV-VCA IgG.
The company is based in the US, and its portfolio consists of Class I medical devices. These products are listed within the FDA 510(k) regulatory registry.
Catalogue
Ebv V Vca Igm Elisa Kit Model# Ebm-200 Ref K020717
Regimes: 510(k) Registry: 510(k)Ebv Ea-D Igg Elisa Kit, Model Ebg-100 Ref K021793
Regimes: 510(k) Registry: 510(k)Ebv-Ebna Igg Elisa Kit, Model Ebg-100 Ref K020707
Regimes: 510(k) Registry: 510(k)Ebv-Vca Igg Elisa Test, Model Ebg-100 Ref K020706
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pan Bio Pty., Ltd. have in the registry?
The registry currently lists 4 devices for Pan Bio Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pan Bio Pty., Ltd.'s devices?
Among its 4 most recently registered devices, Pan Bio Pty., Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Pan Bio Pty., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Pan Bio Pty., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pan Bio Pty., Ltd. in the registry?
The most recently registered devices listed for Pan Bio Pty., Ltd. include EBV V VCA IGM ELISA KIT MODEL# EBM-200, EBV EA-D IGG ELISA KIT, MODEL EBG-100, EBV-EBNA IGG ELISA KIT, MODEL EBG-100 and EBV-VCA IGG ELISA TEST, MODEL EBG-100.