- Assay that allows determining the presence of the pathogenic allele c.*97G>A (NM_000506.4) and the normal allele of the F2 gene in a single PCR reaction.
- It includes a positive control that simulates a heterozygous genotype and that guarantees the functionality of the PCR system and helps the interpretation in the qualitative analysis.
- Validated using the same real-time PCR program as the products related to alterations in the coagulation process, so they can be analyzed together.
- It complies with the quality requirements specified by ISO 13485 and ISO 14001 in relation to the materials used in its manufacturing process.
- For in vitro diagnostic use.
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