Taiwan FDA registration c45ff11208cdb8a3c2f84700831a3626
The second generation of the Roche EGFR Gene Mutation Test Kit
TW: 羅氏EGFR基因突變檢驗套組第二代
Taiwan·Risk Class 3·Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH·Registered Oct 27, 2016 – Oct 27, 2026ActiveRegistration details
- Analysis ID
- c45ff11208cdb8a3c2f84700831a3626
- Customs Code
- DHA05602893508
Company information
- Manufacturer Country
- United States;;Germany
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is an instant PCR detection reagent, targeting the DNA of human non-small cell lung cancer (NSCLC) tumor tissue with formalin-fixed paraffin-embedded (FFPET) or the epidermal growth factor receptor (EGFR) gene exon 18, 19, and plasma of human non-small cell lung cancer (NSCLC) patients. Mutations of 20 and 21 are qualitatively detected and identified. This test can assist in the selection of human non-small cell lung cancer (NSCLC) patients who can be treated with EGFR tyrosine kinase inhibitor (TKI). This product is used in plasma to further semi-quantitatively measure EGFR gene 18, 19, 20 and 21 mutations in human plasma collected over a period of time, and to assist in the management of human non-small cell lung cancer (NSCLC) patients. Formalin-fixed paraffin-embedded (FFPET) samples were treated using the Roche DNA Extraction Kit, while plasma samples were treated with the Roche Free DNA Extraction Kit. This product is used with the Cobas Z 480 analyzer for automated amplification reaction and detection procedures.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- import
Dates and status
- Registration Date
- Oct 27, 2016
- Expiry Date
- Oct 27, 2026
About this record
Access comprehensive regulatory information for The second generation of the Roche EGFR Gene Mutation Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number c45ff11208cdb8a3c2f84700831a3626 and manufactured by Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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