TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06974591043040

Basic UDI-DI Code

B-06974591043040

Reference

KLM-300110

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Creative Biosciences (Guangzhou) Co., Ltd.

Intended for qualitative detection of SDC2 gene methylation level in human stool sample in vitro. The kit is applicable for auxiliary diagnosis of patients who are recommended by clinicians for colonoscopy. The test result alone cannot be used as the basis for early diagnosis or diagnosis of intestinal tumor, but only as an auxiliary diagnosis result for clinicians to refer to and provide patient with more options for auxiliary diagnosis of colorectal cancer. Clinicians should make a comprehensive judgment on the test results based on presenting factors such as the patient's condition and other laboratory test indicators.

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