Performance evaluation and validation studies for rapid diagnostic tests conducted in-house with full-time scientific staff. Includes complete study documentation and regulatory reporting.
Manufactured by
Heidelberg, Germany
Manufacturing & Full Service – We are a manufacturer of human biospecimens and offer individual solutions for all kinds of diagnostic issues. Regardless of whether it concerns rare analytes or specific blood products: We produce over 90% of our blood plasma, as well as serum and plasma samples, under GLP conditions in our own donation centers and through our global networks. With our 120 employees (more than 50% of whom are scientific staff) and numerous test systems (immunology, clinical chemistry, NAT, PoC), we offer you much more than just a provision of human biological samples.
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Biofortuna Limited
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Biofortuna Limited · United Kingdom
Service to conduct accelerated stability testing of diagnostic assays and medical products. Evaluates long-term performance and expiration dating for regulatory submission.
Viprecision Sdn Bhd · Malaysia
Specialized assay development and research support services for rapid diagnostic tests, including feasibility studies, prototype evaluation, and pilot lot production. Services include lateral-flow and molecular biology assay development with quality control oversight.
in.vent Diagnostica GmbH · Germany
Comprehensive analytical and clinical performance evaluation studies for diagnostic assays with CE marking support.
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