CLINICAL CHEMISTRY REAGENTS - OTHER
Basic Information
- Primary DI
- D-IVD21QP019B
- Basic UDI-DI Code
- B-IVD21QP019B
- Reference
- IVD21QP010024CE, IVD21QP010048CE
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Singlera Medical Technologies Co.,Ltd.
Additional Description
This kit is intended for the in vitro qualitative detection of the methylation of Septin9,IKZF1,Septin9-2,B4GALNT1,GRASP,BEST4,BEND4 genes in human plasma samples. The product is suitable for patients with early symptoms of liver cancer，imaging abnormalities, serological abnormalities or patients who have been diagnosed and recommended by clinicians for further examinations. It is used for clinical auxiliary diagnosis of liver cancer, which serves for clinician’s reference only. A positive detection result can not be used as a basis for diagnosis ,which needs comprehensive evaluation based on the patient’s clinical situation. A negative result can not be used to rule out the possibility of liver cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01019099 | CLINICAL CHEMISTRY REAGENTS - OTHER |
| W01060299 | TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER |
Similar Devices
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