| Product Name | PCR-based Diagnostic Device |
| Catalog No. | RDD-QCY-0002 |
| Description | This device is designed to qualitatively detect and classify variants in the protein-coding regions and intron/exon boundary regions of the BRCA1 and BRCA2 genes using polymerase chain reaction (PCR) and sequencing technology. The assay identifies single nucleotide variants and small insertions/deletions. |
| Certification | FDA |
| Application | Used for the qualitative detection of mutations in the protein-coding regions of the BRCA1 and BRCA2 genes, as well as in the intron/exon boundary regions. |
| Sample Types | Whole blood |
| Test Time | average 14 days |
| Features | Precision: From hereditary cancers to precision medicine, delivering the most accurate answers possible. Actionability: Each test provides actionable results within 14 days, informing cancer treatment decisions. |
| Instructions for Use | Collect and transport whole blood samples. Extract genomic DNA. Process DNA using sequencing technology. Analyze variant genotyping results. Generate result reports. |
| Storage | Store in a cool, dry place at temperatures between 5°C and 30°C, away from direct sunlight. |
For in vitro diagnostic use.
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