德國(guó)Sifin抗A抗B原料
德國(guó) SIFIN 抗A抗B原料
1. 創(chuàng)新基于傳統(tǒng)
SIFIN GmbH 成立于 1991 年，基地位于柏林，前身可追溯到 19 世紀(jì)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(yǎng)基國(guó)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(shì)來(lái)源于經(jīng)驗(yàn)
SIFIN 的核心優(yōu)勢(shì)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(xì)菌性病原體的檢測(cè)和血清型分類的檢驗(yàn)血清和檢驗(yàn)試劑：沙門(mén)氏菌屬，志賀
菌屬，小腸結(jié)腸炎耶爾森菌， 大腸桿菌。
微生物培養(yǎng)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(xì)胞培養(yǎng)技術(shù)作為核心技術(shù)。
單克隆抗體被引入傳統(tǒng)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(cè)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(zhuǎn)換為單克隆抗體，這
是常規(guī)檢驗(yàn)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(rèn)證的 SIFIN 是您開(kāi)展研究和體外醫(yī)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(yī)療產(chǎn)品，符合 Directive 98/79/EC（IVD Directive）的定義和要求，因此執(zhí)行
CE 標(biāo)簽。僅供研究使用。
檢驗(yàn)試劑，單克隆抗體產(chǎn)品（Enteroclons）和檢驗(yàn)血清
檢驗(yàn)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(yàn)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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