The product is intended for in vitro diagnosis only. The test result must not be used as the sole index to evaluate the patient's condition, and the patient's clinical manifestation and other laboratory tests must be combined to perform a comprehensive analysis of the condition. Inspection of the product packaging and seal and expiration date is required before performing the test. The test should be performed as soon as possible. Exposure of the test to air and moisture for an extended period of time will result in invalid results. Overloading the specimen may cause unexpected results, such as false positives. The accuracy of the test may be affected by ambient temperature (40°C) and relative humidity (>80%).
View current HSC list
2021-10-20 Added to mutual recognition list
Calibrant / control sample
Type of antigen
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements