HER-2/NEU (BREAST CANCER)
Basic Information
- Primary DI
- 06975977072005
- Basic UDI-DI Code
- B-06975977072005
- Reference
- 600200
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Probe Diagnostic Biotechnology Inc. MF
Additional Description
This kit uses fluorescence in situ hybridization to detect the HER2 gene amplification status in-vitro. The test sample is a paraffin-embedded specimen of breast cancer tissue. The product has not been clinically validated in conjunction with HER2 targeted therapies, and its clinical testing capabilities have been confirmed by comparative trial studies with companion diagnostics that have targeted drug validation. The test results of the product should not be used as the sole basis for individualized treatment. The clinician should make comprehensive judgment on the test results in combination with the patient's condition, drug indications, treatment response, and other laboratory testing indicators.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01060213 | HER-2/NEU (BREAST CANCER) |
Similar Devices
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