GENEDIAN
Basic Information
- Primary DI
- D-RA013UJ
- Basic UDI-DI Code
- B-RA013UJ
- Reference
- P122-07048
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou DIAN Biotechnology Co., Ltd.
Additional Description
This product is intended for in-vitro qualitative testing of methylated modification abnormality of the promoter region of the TAFA4 and Septin9 genes in the cervical exfoliated cell DNA specimen based on double PCR technique (HeavyMethyl duplex PCR) specific to heavy methylation. This product is suitable for risk management of the subject with positive HPV test results or TCT results ≥ASC-US. This product is intended for aided clinical diagnosis of cervical cancer. A positive test result should not be used as the evidence of the confirmation of cervical cancer, while a negative test result cannot exclude the probability of cervical cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
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