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BAG HISTO TYPE Rainbow QS6 Instructions For Use Manual
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EN Instructions for UseHISTO TYPE Rainbow QS6Test kit for the determination of HLA alleles on a molecular genetic basisIVD 0123REF 728221Contents1. INTENDED USE ...................................................................................................................... 22. PRODUCT DESCRIPTION ...................................................................................................... 23. TEST PRINCIPLE .................................................................................................................... 24. MATERIAL ............................................................................................................................... 34.1 Contents of the HISTO TYPE Rainbow QS6 kit ....................................................................... 34.2 Additionally required reagents and devices .............................................................................. 34.3 Validated real time-PCR Cycler ................................................................................................ 35. STORAGE AND STABILITY .................................................................................................... 46. TEST PROCEDURE ................................................................................................................ 46.1 Precautions and special remarks ............................................................................................. 46.2 DNA Isolation ........................................................................................................................... 46.3 Entering sample information into PlexTyper® Software ............................................................ 56.4 Amplification ............................................................................................................................ 56.5 Export of results from QuantStudio™ 6 Flex System ............................................................... 96.6 Evaluation and interpretation of the results ............................................................................ 106.7 Import of the results file into the PlexTyper® software ............................................................ 117. WARNINGS AND DISPOSAL INSTRUCTIONS .................................................................... 128. KIT SPECIFICATIONS .......................................................................................................... 138.1.1 Diagnostic sensitivity and specificity ........................................................................ 138.1.2 Analytical sensitivity and measuring range .............................................................. 138.1.3 Analytical specificity / cross reactive substances ..................................................... 149. LIMITS OF THE METHOD ..................................................................................................... 1410. INTERNAL QUALITY CONTROL........................................................................................... 1411. TROUBLESHOOTING ........................................................................................................... 1512. TRADE NAMES USED .......................................................................................................... 1513. EXPLANATION OF THE SYMBOLS USED ON THE LABELS .............................................. 1614. LITERATURE ........................................................................................................................ 1615. REVIEW HISTORY ................................................................................................................ 16Version: 02/2021 / Issue: 2021-06 |
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