CA125 Fast Test Kit (Immunofluorescence Assay)

Primary DI

06954414702675

Basic UDI-DI Code

B-06954414702675

Reference

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Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Getein Biotech, Inc.

CA125 Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative detection of carbohydrate antigen 125 in human serum and plasma samples. It is used as an aid in monitoring ovarian cancer remnants and recurrence in patients with ovarian tumours and assessing the risk of ovarian cancer in women presenting with pelvic masses around the time of menopause. For professional use only.

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