Cambridge Diagnostics Ireland, Ltd.
IE Last updated 22 Oct 2026
- Devices
- 4
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Human Lyme Igm Western Blot Kit Ref K970768
Inverness Medical Early Pregnancy Test Ref K013907
Selfcare Early Pregnancy Test Ref K955903
What Cambridge Diagnostics Ireland, Ltd. makes
The company produces in vitro diagnostic tests for Lyme disease, including IgM and IgG Western blot kits, and urine-based pregnancy tests for early detection, both for professional and self-care use.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. The company is based in the United States.
Frequently asked questions
What types of medical devices does Cambridge Diagnostics Ireland, Ltd. manufacture?
Cambridge Diagnostics Ireland, Ltd. specialises in in vitro diagnostic tests. Their portfolio includes Western blot kits for detecting Lyme disease (IgM and IgG) and urine-based pregnancy tests designed for early detection. These tests are intended for both professional laboratory use and self-care applications.
Where is Cambridge Diagnostics Ireland, Ltd. based?
The company is based in the United States. While the name includes 'Ireland,' the operational headquarters and regulatory filings are aligned with the US market.
Which regulatory registries or databases list Cambridge Diagnostics Ireland, Ltd.’s devices?
The company’s devices are listed in the FDA’s 510(k) clearance registry. This registry tracks Class II medical devices that have undergone the required pre-market notification process to demonstrate substantial equivalence to a legally marketed predicate device.
How are Cambridge Diagnostics Ireland, Ltd.’s devices classified under FDA regulations?
All of the company’s listed devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices are authorised via the 510(k) clearance process.
Information
- Country
- IE