INTENDED USE

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1 URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1) CAT. NO. UC5033 LOT NO. 867UC SIZE: 12 x 12 ml EXPIRY: GTIN: INTENDED USE This product is intended for in vitro diagnostic use, in the quality control of urine test strips. DEVICE DESCRIPTION The Urinalysis Controls are supplied at 2 levels, level 1 and level 2. Ranges are supplied for the following analytes: Albumin, Bilirubin, Blood, Creatinine, Glucose, HCG, Ketones, Leukocytes, Nitrite,, Protein, Specific Gravity and Urobilinogen. SAFETY PRECAUTIONS AND WARNINGS For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents. Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-REACTIVE. FDA approved methods have been used to conduct these tests. However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly. Health and Safety Data Sheets are available on request. STORAGE AND STABILITY OPENED: Store refrigerated (+2 C to +8 C). The Urinalysis Control is stable for 30 days at +2 C to +25 C, or 20 immersions if kept capped in original container and free from contamination. Do not freeze. UNOPENED: Store refrigerated (+2 C to +8 C). Stable to expiration date printed on individual vials. PREPARATION FOR USE The Urinalysis Control is supplied ready for use. MATERIALS PROVIDED Urinalysis Control - Level 1 12 x 12 ml ASSIGNED VALUES Each batch of Urinalysis Control is submitted to a number of external laboratories and values are assigned from a consensus of results obtained by these laboratories. With each batch, a control range is provided for individual parameters and each parameter method. PAGE 1 OF 8

2 生产厂家或方法学分析物参考范围 77 Elektronika kft 白蛋白胆红素潜血葡萄糖酮体白细胞亚硝酸盐蛋白质尿比重尿胆素原 / Abon hcg One Step Ultra hcg Acon Laboratories hcg Acon Mission Alere hcg Cassette Analyticon Combiscreen Arkray / Menarini hcg 胆红素潜血葡萄糖酮体白细胞亚硝酸盐蛋白质尿比重尿胆素原.5 NEG 0.2 EU/dl / NEG 0.2 mg/dl / NEG 3.5 µmol/l / (0 0.1 g/l) (0 10 mg/dl) (0 0.6 mmol/l) +/- / / EU/dl / mg/dl / µmol/l Bio Chemical Technology Co Ltd hcg PAGE 2 OF 8

3 BioMaxima BM Uri Strip Chung-do Pharmaceuticals NEG 0.1 mg/dl / NEG 1.6 µmol/l CTK Biotech Onsite hcg hcg DFI - Cybow DFI ComboStik 5 7 / 0.1 EU/dl / 0.1 mg/dl / 1.6 µmol/l 5..5 / 0.1 mg/dl / 1.6 µmol/l PAGE 3 OF 8

4 Dirui H Series 白蛋白胆红素潜血肌酐葡萄糖 0.9 mmol/l 酮体白细胞亚硝酸盐.5 +/- / / µmol/l Erba Lachema Erba Mannheim Uro-Dip.5 Gabmed beta 10 hcg Cassette hcg Greats Medtech hcg Strip hcg Human Combina 白蛋白胆红素潜血肌酐葡萄糖酮体白细胞亚硝酸盐蛋白质尿比重 10 mg/l 10 mg/dl / 0.9 mmol/l Human Rapid Pregnancy Tests hcg IND Diagnostic hcg hcg PAGE 4 OF 8

5 Iris Velocity 胆红素潜血葡萄糖酮体白细胞亚硝酸盐 RATIO Macherey-Nagel Menarini Mindray 0 1 mg/dl / 0 17 µmol/l +/- / mg/dl RATIO / / 0.2 mg/dl / 3.2 µmol/l Nal von Minden Nadal hcg hcg Neopharma Sensatest hcg Nova Century Scientific hcg Quidel Quickvue / Rapidvue hcg PAGE 5 OF 8

6 Roche Combur 白蛋白 RATIO / 0.2 EU/dl Roche Miditron / u411 / u601 Roche Urisys 1100 / 1800 / 2400 Siemens Clinitek Novus / >1.03 RATIO / 0.2 EU/dl / 3.2 µmol/l PAGE 6 OF 8

7 Siemens Multistix 白蛋白胆红素潜血肌酐葡萄糖酮体白细胞亚硝酸盐 1 mg/dl / 10 mg/l / 6.9 mmol/l mg/dl / mmol/l >1.03 RATIO / 0.2 EU/dl / 0.2 mg/dl / 3.2 µmol/l Siemens / Bayer Clinitek 白蛋白 1 mg/dl / 10 mg/l / 6.9 mmol/l 肌酐 mg/dl / mmol/l Standard Diagnostics hcg Standard Diagnostics Urocolor Sysmex Meditape II 9U Teco Diagnostics +/- / mg/dl / 1.6 µmol/l EU/dl / 0.2 mg/dl / 3.2 µmol/l True BioScience hcg PAGE 7 OF 8

8 Uritest Medical WH Accu Test hcg Pregnancy Test hcg Wondfo hcg hcg Xuzhou Dongjiu YD Diagnostics / Biosys / Genesis hcg.5 / 1+ / µmol/l ( mg/dl) / +/- / 0.1 mg/dl / 1.7 µmol/l 05 Dec 16 ne PAGE 8 OF 8

免疫多项检测用质控品-水平1

免疫多项检测用质控品-水平1 尿液分析质控品货号 : UC5034 包装 : 12 x 12 ml 批号 : 868UC 效期 : 2017-12-28 产品描述本产品用于体外诊断中尿试纸条和 POCT 检测的质量控制朗道供应两个水平 ( 水平 1:UC5033; 水平 2: UC5034), 并为以下项目提供参考范围 : 白蛋白胆红素葡萄糖人绒毛膜促性腺激素 (hcg) 白细胞亚硝酸盐 ph 值蛋白质尿比重尿胆素原