Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

IColocomf

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-AD01-24CE4Z
Basic UDI-DI Code
B-AD01-24CE4Z
Reference
AD01-24CE
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

"This kit is intended for the in vitro qualitative detection of methylated SDC2 and TFPI2 genes in intestinal exfoliated cells from human stool samples. This kit is intended for non-invasive ancillary diagnosis of individuals who are recommended for colonoscopy. It faciliates doctors assess the patient's risk of colorectal cancer or precancerous lesions and determine whether there is a need for further clinical examination."

CND Nomenclature Codes

Code Description
W01060214 COLORECTAL CANCER (MSI-H / DMMR)

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