20 tests/ kit
registration number:CE
product compasition:
20 pcs of Test Devices
20 dropping bottles with buffer (2 mL each)
1 instruction for use
SD card (with specific stand curve file)
Intended use
The CA15-3 rapid test is a chromatographic immunoassay for quantitative measurement of the CA 15-3 tumor associated antigen in human serum or plasma, is indicated for the serial measurement of CA 15-3 to aid in the management of patients diagnosed with breast cancer. The test is useful as an aid in monitoring of disease status in those patients having
confirmed breast cancer who have levels of serum or plasma CA15-3 above the cutoff, at the time of diagnosis.CA 15-3 values must be interpreted in conjunction with all other available clinical and laboratory data before a medicaldecision is determined.