Legionella Urinary Antigen Test from Japan
An immunochromatographic test strip device for detecting Legionella pneumophila serogroup 1 antigen in urine samples. It consists of monoclonal antibodies fixed on a membrane backing and is used for rapid diagnosis of Legionnaires' disease. This is a prepared diagnostic reagent on a backing, not a medicament, so it falls under tariff item 3822.19.00.
Duty Rate — Japan → Canada
0%
Import Tips
• Ensure the test kits are labelled as in vitro diagnostic devices and comply with Health Canada's Medical Devices Regulations
• Keep certificates of analysis and lot release documents ready for CBSA inspection
• Verify whether the product requires a Medical Device Establishment Licence (MDEL) before import