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    Unicontrol Ii - Greiner

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    Ân Đình

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    Unicontrol Ii - Greiner

    Uploaded by

    Ân Đình
    31 views3 pages

    Original Title

    UNICONTROL II -GREINER

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    31 views3 pages

    Unicontrol Ii - Greiner

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    Ân Đình

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    © All Rights Reserved
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    Unitrol-II Controlserum , pathological, for Control in in quantitative of Accuracy and Preci In vitro Diagnostics ce Q Greiner LOT: 201 069 EXP.: 06-2022 In vitro Diagnosticum Order Information Cat.No.201 000 (10x 5 ml) Storage and sta Unopened bottles must be stored at 2-8 °C and are stable up to the expiration date printed on the labels ‘After reconstitution the serum can be used , stored at 2-8°C and protected from light, in between 5 days. Bilirubin is stable 1 day , refrigerated The frozen serum is stable for at least 30 days at <-20°C Warnings and Precautions Each ind! blood donation used for this serum was found negative when tested with FDA- ‘approved methods on HBsAg, anti-HIV 1+2 and anti-HCV. Nevertheless the serum should be treated for safety reasons always as a potential infectious material Preparation Reconstitute carefully by adding exactly § ml of distilled water. Allow the vial to stand for 30 minutes , swirling occasionally. Avoid foaming i.e. do not shake! Procedure Refer to the package inserts of the reagent kits osr2019 Assay Values and Ranges ‘Assay values for analytes for which approved reference methods are availaule were determined according to Guidelines of the German Federal Medical Council [Bundesaerztekammer] from 1987 (reference method values) (3) Ranges of acceptance were calculated as assigned value + three times the maximum tolerable deviation of a single value according to the Guidelines of the German Federal Medical Council {4}. Literature G, Slekmann L. Quality assurance of laboratory diagnostics. ‘Verlagsgeselischatt Laboratories. U.S. Department of Health and Human Services, Washington 1993 (HHS No, {COC} 93-8395), 3 der Bundesaretekammer zur ‘medizinischen Laboratorien, Untersuchungen. Deutsches ‘Acteblatt 2002;96:8 2747-59, Page 1/1 Greiner Diagnostic GmbH - Unter Gereuth 10 - D-79353 Bahlingen — Germany www greiner. nitro Lot 201089 ‘Component Method Value [AGP (Total Acid Phosphatas Kinet. Colormeine Test Naphihy [Albumin ne pea si ef ‘Kircic Golormatic Test (FCC) Roche a, | Kinetic Colorimetric Test (DEA) Greiner a0. [s-Amylase, Tota l-Amlase, Pancreate (OC DCA, DPD 1 Jeno (Colorimetric Test (Cholesteror |Goledmatic CHOD-PAP Test |HDL-C cholestoral, HDL) Dvect enaymatie Galoraat Greer ao LL ‘Precipitation with PWA/MgCI2 * (LOLS (Cholesterol, LDL) *Dvecr enaymatie Calonaat Genera, (cHE [ex (eK) onus alle -Method | Roche 2.0. |Enzymate Colorimetric Test (PAP - Method ) (ecbH Kin UV-Test (opt DGKC, 37°0) Genero (Gucose THKCUV “Test GOD PAP Test Univ Lot 2otoee ‘Component | Method Value Range Unit feo a lasar aaa ‘re ames or aaa ar larar ie er ta. az ker tags (00 Sen sland) (Gener 2.0) ety [eseDH |Optknet Test Opt DGG) nae ry IRON acim Tes “87 28 rPeraane'ang “Foren Be ies Tai Cocrinete Tet LOO PAP” or WSS 22 ae ast sor ore ret Wes 1 218 3a bee bar [LOH ‘Kinet. UV-Test | 449 645, ook 37°0) | 148. 108 [Lipase [Colorimetric Test ((DGMRE"-Substrate) | 85.9 140 Greiner Lipase-C) 4,43. 2,33 oe Tati Abortion T 178 aa | 41,22 4,56 ges cali Tet Baz an io tse Proseror morgane 3a ai i 2s Poa ear 788 =a iad ue. m8 oii, Tt 1 yaar 78 | er A |Seaium SE, indirect T 186 475 | 2 a oor ‘oimetic GPOPAP Test T ac) 22 ise 276 lowe Ti-Tet (ean Us Galois Batra Tet] 8 @ ‘2 Bt : lUieaaa [Saari Tea 788 ‘a {urease} er ei ne [Nome Abs a a8 im 2 * The value forthe MDL-determination after precipitation 1s very mu depanding on RPM (rotations /min) ‘resp. RCF (relative centrifugal force) (We used an Eppendorf Micro Centrifuge at ca. 10.000 RPI) “IFC Is by EU:IVD defined as “reagent resp test with pyridoxalphosphate added’, ‘otharwise refer tothe local regulaions, or call us for mare information

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