德國Sifin抗A抗B原料
德國 SIFIN 抗A抗B原料
1. 創(chuàng )新基于傳統
SIFIN GmbH 成立于 1991 年，基地位于柏林，前身可追溯到 19 世紀早期。在俾斯麥時(shí)期，
為“Berline Impfanstalt”即柏林疫苗研究所，在 1966 年，被納入流行病控制研究所也叫免
疫制劑與培養基國家研究所。在 1992 年在私人投資者的幫助下，診斷部創(chuàng )立并成功發(fā)展。
2. 優(yōu)勢來(lái)源于經(jīng)驗
SIFIN 的核心優(yōu)勢在于員工的資質(zhì)及多年的實(shí)踐：
Ⅰ.致力于研發(fā)和生產(chǎn)：
用于小腸炎細菌性病原體的檢測和血清型分類(lèi)的檢驗血清和檢驗試劑：沙門(mén)氏菌屬，志賀
菌屬，小腸結腸炎耶爾森菌， 大腸桿菌。
微生物培養基
血型分型試劑
Ⅱ.單克隆抗體生產(chǎn)體系的確立
從 80 年代中期免疫制劑的生產(chǎn)就開(kāi)始采用雜交瘤細胞培養技術(shù)作為核心技術(shù)。
單克隆抗體被引入傳統的血型分型產(chǎn)品和沙門(mén)氏菌屬，志賀氏菌屬，大腸桿菌包括腸出血性
大腸桿菌診斷用的檢測試劑中。
特別是，沙門(mén)氏菌的診斷，我們已經(jīng)將大部分凝集試劑從多克隆抗體轉換為單克隆抗體，這
是常規檢驗和流行病學(xué)的里程碑。
3. 質(zhì)量領(lǐng)先
獲得了以下質(zhì)量管理認證的 SIFIN 是您開(kāi)展研究和體外醫療產(chǎn)品研發(fā)工作的好幫手：
·ISO 9001:2008‐12
·ISO 13485:2003
·Quality System and EC Design Examination acc.to Council Directive 98/79/EC
4. 產(chǎn)品說(shuō)明
所有制劑都是醫療產(chǎn)品，符合 Directive 98/79/EC（IVD Directive）的定義和要求，因此執行
CE 標簽。僅供研究使用。
檢驗試劑，單克隆抗體產(chǎn)品（Enteroclons）和檢驗血清
檢驗試劑由兔抗血清和單克隆抗體混合物或僅僅由單克隆抗體組成。在 SIFIN，只含有單克
隆抗體的檢驗試劑叫 Enteroclon
? Monoclonal antibody availble in concentrate or ready-to-use bulk format
MAb Clone Properties Isotype
Anti-A A-11H5 Murine monoclonal antibody strongly reacts with red blood cells of the blood groups A1, A2, A1B and A2B. Agglutinates A3 red blood cells (mixed field aggluti- nation), reaction with Ax red blood cells usually positive. IgM
Anti-A A-5E10 Murine monoclonal antibody strongly reacts with red blood cells of the blood groups A1, A2, A1B and A2B. Agglutinates A3 red blood cells (mixed field aggluti- nation), reaction with Ax red blood cells usually positive. IgM
Anti-B B-6F9 Murine monoclonal antibody strongly reacts with red blood cells of the blood groups B, A1B und A2B. Does not react with ?acquired“ B. IgM
Anti-B B-2D7 Murine monoclonal antibody strongly reacts with red blood cells of the blood Groups B, A1B und A2B. Does not react with ?acquired“ B. IgM
Anti-D BS225 Human monoclonal antibody strongly reacts with red blood cells with normally expressed D antigen. Weak D red blood cells are agglutinated subject to the antigen density. Category VI is not detected among the partial D antigens. IgM
Anti-D NaTH119 Human monoclonal antibody strongly reacts with red blood cells with normally expressed D antigen. Weak D red blood cells (types 1-4) are agglutinated subject to the antigen density. Categories IV and VI are not detected among the partial D antigens. IgM
Anti-D LOR-15C9 Human monoclonal antibody strongly reacts with red blood cells with normally expressed D antigen. Weak D red blood cells (types 1-3) are agglutinated subject to the antigen density. Categories II, III, Va, VI and VII are agglutinated among the partial D antigens. IgG
Anti-M A-46/B/B-10 Murine monoclonal antibody strongly reacts with red blood cells of the blood groups 0, A2 and A2B positive; with A1 and A1B weak positive or negative. lgM
Anti-M M11H23 Murine monoclonal antibody specifically agglutinates red blood cells with M Antigen. lgG1
Anti-N N-20H12 Murine monoclonal antibody specifically agglutinates red blood cells with N antigen after correction of pH to 8.6 - 8.9. lgG2b
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