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+M 53D - A11 000136 - 2019062001 PDF
+M 53D - A11 000136 - 2019062001 PDF
Certificate of Analysis
No. COA20190625012
产品名称 血细胞分析用稀释液
Product Name M-53D DILUENT
批号 型号
2019062001 M-53D
Lot No. Model of the Reagent
物料编码 包装规格
A11-000136--- 20 L
Material Code Package Size
生产日期 有效期
2019-06-20 2021-06-19
Manufacture Date Expiry date
标准依据
产品检验规范 Specification for Product Inspection
Standard basis
应为澄清液体,不得有沉淀、颗粒或絮状物
外观
Appearance 符合标准/Qualified 符合/Pass
Must be clear liquid,without deposition, particle
and floccule
2、装量
Volume
装量
Volume ≥20L 20.0 L 符合/Pass
3、性能
Performance
pH值
pH Value 6.90±0.20 (25℃±1℃) 6.90(25.1℃) 符合/Pass
BC-5300 BC-5300
HGB相对偏差在 ±3.5% 范围内
HGB:2.08%
Relative Deviation in ±3.5% range
MCV相对偏差在 ±3.0% 范围内
MCV:0.32%
Relative Deviation in ±3.0% range
准确性 PLT相对偏差在 ±12.5% 范围内
Accuracy PLT:4.81% 符合/Pass
Relative Deviation in ±12.5% range
RBC相对偏差在 ±3.0% 范围内
RBC:2.91%
Relative Deviation in ±3.0% range
WBC相对偏差在 ±7.5% 范围内
WBC:4.76%
Relative Deviation in ±7.5% range
渗透压
Osmotic pressure 285±10 mOsm/Kg 286 mOsm/kg 符合/Pass
电导率
Conductance 1700±50 mS/m (25℃±1℃) 1681 mS/m(25.3℃) 符合/Pass
BC-5300 BC-5300
HGB≤1 g/L HGB:0 g/L
大于等于2.5fL的粒子数目≤2.5×10^5/L
粒子计数
Particle Counting The number of particles greater than or equal to 1.0 ×10^5/L 符合/Pass
2.5fL must not be greater than 2.5×10^5/L
深圳迈瑞生物医疗电子股份有限公司
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
地址:深圳市南山区高新技术产业园区科技南十二路迈瑞大厦 邮编:518057 电话:0755-8188 8998 传真:0755-26582680
Adress:Mindray Building, Keji 12th Road South, High-Tech Industrial Park,Nanshan, Shenzhen, 518057, P.R. China
Tel:+86 755 8188 8998 Fax:+86 755 26582680 Website:www.mindray.com
Q-0003-027-SJ-3.0 第 1页 共 2 页 Page 1 of 2
结论
合格/PASS
Summary
备注
Remarks
深圳迈瑞生物医疗电子股份有限公司
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
地址:深圳市南山区高新技术产业园区科技南十二路迈瑞大厦 邮编:518057 电话:0755-8188 8998 传真:0755-26582680
Adress:Mindray Building, Keji 12th Road South, High-Tech Industrial Park,Nanshan, Shenzhen, 518057, P.R. China
Tel:+86 755 8188 8998 Fax:+86 755 26582680 Website:www.mindray.com
Q-0003-027-SJ-3.0 第 2页 共 2 页 Page 2 of 2