A diagnostic test kit for detecting the Factor V Leiden mutation (G1691A), one of the most common genetic risk factors for thrombophilia. The kit contains reagents for 32 tests and is available for QiaSymphony SP/AS systems. It is CE Mark certified.
Manufactured by
CLONIT SRL
Abbiategrasso, Italy
Since 1987, Clonit has been focused in developing, manufacturing and distributing of innovative and reliable in Vitro Diagnostic Equipment and Reagents for Molecular Diagnostics. A deep expertise in Molecular Biology mixed to our strong culture of business ethics make our company a valued partner for laboratories and hospitals around the world. With our high standard and high performance IVDs portfolio, we aim to improve healthcare by enhancing and supporting the decision-making process, in line with scientific and technological evolution. Our clinical diagnostic products are used to detect a broad range of diseases in several key areas such as viral, bacterial and fungal infections (including sexually transmitted diseases, transplantation/immunocompromised related infections, tropical diseases, healthcare associated infections), thrombophilia, oncohematology and several genetic disorders . The standardization of internal quality control system and cross-checks in external reference labs allow Clonit to ensure application of the highest standards of care and quality (ISO 9001 and ISO 13485 Certified). Recently Clonit obtained the certification of products according to EU 2017/746 Regulation on In Vitro Diagnostic Medical Devices (IVDR). Certification for Class C products was issued by TÜV SÜD Product Service The company is registered and authorized by the Italian Ministry of the Health for the development, manufacturing and commercialization of Medical Diagnostic devices. We listen carefully to our customers’ needs and work closely with health care professionals to transform them into solutions that provide people a better quality of life.
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Advanced Molecular Diagnostics Ltd. · United Kingdom
PCR-based assay for detecting Factor V Leiden mutation linked to increased thrombosis risk. Provides genetic screening for inherited coagulation disorders.
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Specialized assay for Factor V Leiden mutation detection through coagulation analysis. Supports thrombophilia screening on automated coagulation platforms.
Attomol GmbH - Molekulare Diagnostika · Germany
A diagnostic test kit for detecting the Leiden mutation (1691G>A) in the Factor V gene. The kit contains 40 test determinations and is used to identify this common genetic risk factor for thrombosis.
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