Instructions for hemolytic agents for blood cell analysis

　　[product name]]hemolytic agent for blood cell analysis

　　[Model]]SC-hemolytic agent A- MDF

　　[packing specification]]500ml 、 1L 、 2L × 2 、 4L 、 4L × 2 、 5L 、 20L

　　intended use]It is used to destroy red blood cells, dissolve hemoglobin, and maintain the morphology of the cells to be analyzed before blood cell analysis, thereby facilitating cell classification and counting or quantitative determination of hemoglobin.

【inspection principle]]Lysis of red blood cells, keep the white blood cell morphology unchanged, for the instrument white blood cell count classification.

　　main component]quaternary ammonium salt

　　Storage conditions and period of validity]Lightly loaded and unloaded, piled up according to the arrow signs, stored in a dry, well-ventilated, clean room at 2 ℃ ~ 35 ℃, valid for 18 months. The production date and expiration date are shown in the product bottle label or outer packaging.

　　Applicable models]Hyssenmecom Series Hematology Analyzer

　　sample requirements]According to the specification of the analytical instrument: EDTA-K₂Anticoagulation, detected within 4 hours.

　　test method]Carefully read the operating instructions of the adapted instrument and connect it as indicated in the instructions.

　　reference interval]In line with the normal reference value of supporting analytical instruments: white blood cell count (WBC):4.0-10.0 ×10⁹  /L; Percentage of large cells:(NE%)>50%-70%; Small cell percentage (LY%):20%-40% median cell percentage (MO%)>3%-12% HGB: male: 120-160g/L, female: 110-150g/L, newborn: 170-200g/L.

　　interpretation of test results]The test results cannot completely replace manual microscopic examination. The analysis results are as follows: 3.5 ×10⁹  /L>WBC>12.0 ×10⁹  /L;> percentage of large cells:(NE%)>85%; Percentage of small cells (LY%): adult> 50%, child> 60% median cell percentage (MO%)>15%; Artificial microscopy should be carried out when there is an instrument alarm prompt. Leukemia patients due to white blood cell particles caused by increased turbidity, resulting in high results, it is recommended to use HiCN method after centrifugation for colorimetric determination.

　　Limitations of test methods]Some specimens may not be classified, and manual microscopy should be performed at this time.

　　product performance index]pH = 5.9±0.5(25 ℃ ± 1 ℃).

　　[Note]]1. Prevent dust from entering and prevent freezing.

2. Use up within 60 days after opening.

3. The used products shall be disposed according to the provisions of medical waste treatment.

   References]Cong Yulong, Le Jiaxin. Modern Blood Cell Analysis Technology and Clinical. Beijing: People's Military Medical Publishing House, 2 005,119-123

　　Specification Approval Date]Enacted on April 20, 2023

Abbreviation explanation]

	In vitro diagnostic reagents		Batch Number		Keep away from light
	Valid		Manufacturer		Storage temperature		Reference Description Time

　　production enterprise]Company: Hubei Shuocheng Medical Biotechnology Co., Ltd.

Registered Address: No.19 Dongcheng Road, Dongcheng Experimental Zone, Yiling District, Yichang City

Production Address: No.19 Dongcheng Road, Dongcheng Experimental Zone, Yiling District, Yichang City

After-sales service address: No.19 Dongcheng Road, Dongcheng Experimental Zone, Yiling District, Yichang City

Tel: 0717-6612088

Zip Code: 443100

[Record No. of Class I Medical Device Manufacturing Enterprise]]E Yi Yao Jian Xie Production No. 20230002

[Medical Device Filing Voucher No.]]E Yi Xie At No. 20230025

[product technical requirement number]]

Our vision: the company has a 3000 ㎡ production workshop, and is equipped with a professional central laboratory and advanced supporting analysis and research equipment and inspection equipment. Safe and efficient production conditions and perfect production management system provide a strong guarantee for enterprises to produce high quality products. Shuocheng Biomedical adheres to the business philosophy of "people-oriented, honest management, innovation and leadership, and quality first", and has long been committed to casting excellent quality and providing perfect after-sales service. Sincerely welcome your cooperation, create a better tomorrow!