MRN ANALYTICAL TESTING SERVICES
The MRN Analytics department is the testing division of MRN Diagnostics, performing validation testing, clinical testing, point of care testing, and release testing for internally manufactured controls. We strive to provide accuracy and consistency within the variety of tests that we perform.
Our mission is to aid developers in validating their diagnostic products through a complete selection of certified testing platforms and algorithms.
ANALYTICAL SERVICES
REGISTRATIONS
MRN Diagnostics proudly holds multiple registrations, permits, and licenses to run our business at the highest level of Quality and compliance. MRN Diagnostics continually strives to achieve the highest level of customer service and compliance in our industry.
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ISO 13485:2016
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FDA Blood Establishment
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FDA Registered Manufacturer
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CDC Import Permits
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CLIA Waived (CLIA to be in place by Q3 2023)
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Clinical Laboratory Licensed (COVID-19)
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USDA Permit to transfer in the US
TESTING PLATFORMS
We screen and qualify materials for a variety of projects for both internal and client-requested projects using a variety of different testing platforms and assays. Platforms we currently utilize include:
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Abbott Architect i2000SR
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Ortho VITROS® ECiQ
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Siemens ADVIA Centaur® XP
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Cepheid® GeneXpert.
UNTRAINED-USER LABS
An important branch of our department includes testing for clinical studies and collections, as well as point-of-care studies where our employees may act as untrained users for newly developed assays.
VALIDATION TESTING
In concert with our manufacturing division, we perform validation testing on many controls manufactured here at MRN Diagnostics which can include studies like use life, shelf life, precision, and freeze/thaw cycling to challenge the controls we develop and ensure their continued performance for our clients and customers.MRN Analytics' testing capabilities include, but are not limited to, testing of rapids, ELISAs, colorimetric assays, and bacterial limit-of-detection studies.
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