Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)

Organization name

GeneMind Biosciences Co., Ltd.

SRN

CN-MF-000025785

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Türkiye; available across 1 country total.

Placed on the market in Türkiye; per-country availability dates not published.

Trade name

Solid Tumor Multi-gene Combined Detection Kit ( Reversible Terminator Sequencing)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

06974968583179

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-06974968583179

Reference / catalog number

L000044

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Cancer is a complex polygenic disease, which is caused by the gradual accumulation of gene mutations. When the genes regulating cell growth are mutated or damaged, the cells lose control and proliferate indefinitely, leading to the emergence of malignant tumors. Tumor individualized diagnosis and treatment can accurately judge the unique gene mutation information of each solid tumor patient, and provide important reference information for the use of targeted drugs, immunotherapy, chemotherapy drugs, genetic risk, prognosis, and recurrence monitoring. Microsatellite Instability (MSI) refers to the length change of microsatellite (MS) sequence caused by insertion or deletion mutations during DNA replication, which is often caused by mismatch repair (MMR) defects. MS sequences are short and repetitive DNA sequences, which are generally composed of 1-6 nucleotides and arranged in tandem repeats. The common types are dinucleotide repeats of CA/GA/GT or mononucleotide repeats of A/T. MS sequences can be located in the important non-coding region or coding region of genes. Polymorphisms are distributed in the whole genome, with great individual differences. MSI is present in colorectal cancer, endometrial cancer, gastric cancer, hepatocellular carcinoma, breast cancer, and other solid tumors. In clinical application, it can be used for the screening of Lynch syndrome (also known as hereditary non polyposis colorectal cancer (HNPCC)), and the prognosis and medication guide of colorectal cancer. Tumor mutation burden (TMB) generally refers to the number of nonsynonymous mutations in somatic cells in a specific genomic region, which can indirectly reflect the ability and degree of tumors to produce neoantigens. It has been proved that TMB can predict the efficacy of immunotherapy for many kinds of tumors. Tissue TMB can be used as an independent biomarker to predict the efficacy of immunotherapy.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

• IVDD — General medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.