Panbio Limited
Country not established
- Devices
- 8
What Panbio Limited makes
Panbio Limited manufactures diagnostic immunoassay kits for detecting viral antibodies, including tests for West Nile Virus IgM and IgG, as well as Epstein-Barr Virus (EBV) VCA-P18 IgG. These products are designed for laboratory use to identify immune responses to specific pathogens via enzyme-linked immunosorbent assay (ELISA) methods.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with relevant products listed via the 510(k) pathway. These products are intended for use in the United States, where regulatory compliance is required for market authorisation.
Catalogue
Tpp Ref K962176
Regimes: 510(k) Registry: 510(k)Panbio Indx Igm Dip-S-Ticks Leptospirosis Test For The Detection Of Igm Antibodies To Leptospira Biflexa Ref K002024
Regimes: 510(k) Registry: 510(k)West Nile Virus Igm Capture Elisa Ref DEN030004
Regimes: De Novo Registry: De NovoAbs Cadkit Ref K910636
Regimes: 510(k) Registry: 510(k)Ebv Vca-P18 Igg Elisa Ref K030863
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Fif Tm Ref K970189
Regimes: 510(k) Registry: 510(k)West Nile Virus Igg Indirect Elisa Ref K041068
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Panbio Limited have in the registry?
The registry currently lists 8 devices for Panbio Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Panbio Limited's devices?
Among its 8 most recently registered devices, Panbio Limited has devices listed in FDA 510(k) (8 devices).
What risk classes do Panbio Limited's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Panbio Limited's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Panbio Limited in the registry?
The most recently registered devices listed for Panbio Limited include TPP, PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA, WEST NILE VIRUS IGM CAPTURE ELISA and ABS CADKIT.