Shield Diagnostics, Ltd.
Country not established
- Devices
- 27
What Shield Diagnostics, Ltd. makes
Shield Diagnostics, Ltd. manufactures in vitro diagnostic (IVD) immunoassay kits and assays for detecting specific antibodies and biomarkers in human serum or plasma. Products include single-well and profile screening kits for antinuclear antibodies (ENA), anti-centromere, anti-histone, anti-glomerular basement membrane, and anti-Jo-1 antibodies. Additional assays measure von Willebrand factor activity and phenylalanine levels, as well as anti-cardiolipin and anti-SS-B (La) antibodies.
The company’s portfolio comprises Class I and Class II in vitro diagnostic devices, regulated under the FDA’s 510(k) clearance pathway. Devices are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 27 devicesFrequently asked questions
How many devices does Shield Diagnostics, Ltd. have in the registry?
The registry currently lists 27 devices for Shield Diagnostics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shield Diagnostics, Ltd.'s devices?
Among its 27 most recently registered devices, Shield Diagnostics, Ltd. has devices listed in FDA 510(k) (27 devices).
What risk classes do Shield Diagnostics, Ltd.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Shield Diagnostics, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shield Diagnostics, Ltd. in the registry?
The most recently registered devices listed for Shield Diagnostics, Ltd. include DIASTAT ENA SINGLE WELL SCREEN KIT, DIASTAT ANTI-CENTROMERE KIT, SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY and QUANTASE PHENYLALANINE ASSAY.