Lysun

Primary DI

6971771202235

Basic UDI-DI Code

B-6971771202235

Reference

RPS/15/2024

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

hangzhou lysun biotechnology co.,ltd

The One Step Multi-Drug Rapid Test (Urine) detects drugs of abuse through visual interpretation of color development on the internal strip. Drug conjugates are immobilized on the test region of the membrane. During testing, the specimen reacts with antibodies conjugated to colored particles and precoated on the sample pad. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are insufficient drug molecules in the specimen, the antibody-colored particle conjugate will bind to the drug conjugates, forming a colored band at the test region of the membrane. Therefore, a colored band appears in the test region when the urine is negative for the drug. If drug molecules are present in the urine above the cut-off concentration of the test, they compete with the immobilized drug conjugate on the test region for limited antibody binding sites. This will prevent attachment of the antibody-colored particle conjugate to the test region. Therefore, the absence of a colored band at the test region indicates a positive result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).