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Qualification Panels
  • 产地：美国
  • 货号：PF102
  • 发布日期： 2017-06-01
  • 更新日期： 2025-06-04
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产地 美国
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货号 PF102
保存条件 2-8度
英文名称
保质期 18个月个月

    具有超过 25 年的诊断行业经验，SeraCare 通过了 GMP, FDA’QSR(21CFR Part820)、EC1069/2009，EW42/2011 等权威第三方检测和认证，与各 IVD 研究者、生产厂家以及临床实验室均有密切的合作，2013年5月与健仑生物科技建立起战略性合作伙伴，致力于为当前的诊断解决方案和未来的分子诊断以及下一代测序和伴侣诊断新技术之间搭建联系的桥梁，提供可改善诊断质量的产品和服务，以及改善病人治理和预后结果。

开发和生产的产品包括：高质量的质控产品和诊断组份；用于诊断、治疗、药物发现和科研等机构的生物制品和服务，主要有各种疾病的阳性参考物、处理的阴性参考物、panel 和 control。

1. 原 BBI 的各种传染性疾病 panel，包括：性能盘（Performance Panels）、转化盘（Seroconversion Panels）、Sensitivity

Panels、质控盘（Qualification Panels），详情请致电亚洲办公室：020-82574011

2. 各种疾病的 DNA 阳性、抗体阳性、定性或定量的阳性参考物，包括：传染性疾病、自身免疫疾病等，具体产品如附表。

3. 阴性血浆，各种处理过的去纤维人阴性血浆。

这种特殊处理过的阴性血浆，品质稳定，无沉淀物，无颗粒或絮状沉淀，低 bio-burden（<10 CFU/ml (Colony formingunits/ml)）盐分含量接近正常生理指标，且可以根据客户的特定需求定制、加入抑菌剂和分装处理（包括大份包装或者 donor 的性别选择等），也可以根据客户的需求进一步进行 Anti-HBc, anti-HTLV-I/II ，或 Syphilis 等指标的测试，从最初的血样收集到*的成品血浆，保证血样的可追溯性。可作为价格昂贵的阴性血清的替代品，用于生产自控品和校准品的稀释剂以及细胞培养介质使用。

 

SAP CodePart CodeDescription# Vials x Fill SizeCE Status


Qualification Panels








2400-0140QCA702-4.0HIV RNA / HCV/HBV DNA  RNA Qualification Panel 5 x 4.0 mLCE Mark Not Required
2400-0141QHA711-2.0HBsAg Qualification Panel6 x 2.0 mLCE Mark Not Required
2400-0145QHG711-2.0anti-HBc Qualification Panel6 x 2.0 mLCE Mark Not Required
2400-0148QHV712-1.0anti-HCV Qualification Panel   Level 26 x 1.0 mLCE Mark Not Required
2400-0181QRP713-1.5anti-HTLV I/II Qualification   Panel6 x 1.5 mLCE Mark Not Required
2400-0158QRX701-3.5HIV 1/2/O/p24 Qualification   Panel6 x 3.5 mLCE Mark Not Required
2400-0160QRZ761-1.0anti-HIV-1/2 Qualification Panel6 x 1.0 mLCE Mark Not Required
2400-0161QSH701-4.0HPV Qualification Panel25 x 4.0 mLCE Mark Not Required
2400-0163QSS701-2.0Syphilis Qualification Panel6 x 2.0 mLCE Mark Not Required
2400-0164QTC711-3.0anti-CMV Qualification Panel6 x 3.0 mLCE Mark Not Required


Basematrix








1805-0074B001-0008Basematrix 12 x 3.5 mLCE Mark Not Required
1805-0075501101Basematrix 531 x 1 LiterCE Mark Not Required


HIV Performance   Panels








0800-0238PRA204-1.5HIV p24 Antigen Mixed Titer   Performance Panel25 x 1.5 mLCE Mark Not Required
0800-0237PRA204(B)-1.5HIV p24 Antigen Mixed Titer   Performance Panel12 x 1.5mL CE Mark Not Required
0800-0241PRB109-1.0anti-HIV 1 Low Titer Performance   Panel20 x 1.0 mLCE Mark Not Required
0800-0246PRB205(M)-1.0anti-HIV-1 Mixed Titer   Performance Panel 24 X 1.0 mLCE Mark Not Required
0800-0248PRB601-1.0HIV-1 Incidence/Prevalence   Performance Panel15 x 1.0 mLCE Mark Not Required
0800-0249PRD201-1.2HIV 1 Genotype Performance Panel9 x 1.2 mLCE Mark Not Required
0800-0250PRD202-1.1HIV RNA Genotype Performance Panel10 x 1.1 mLCE Mark Not Required
0800-0251PRD250-1.0Teragenix HIV Drug Resistance Performance Panel10 x 1.0 mLCE Mark Not Required
0800-0255PRF203-1.0HIV-2 Mixed Titer Performance   Panel11 x 1.0 mL CE Mark Not Required
0800-0261PRZ208-0.25anti-HIV-1/2 Combo Performance   Panel15 x 0.25 mLCE Mark Not Required
0800-0235WWRB305-0.5WW HIV Performance Panel20 x 0.5 mLCE Mark Not Required


Hepatitis Performance Panels








0805-0183PHA107-1.5HBsAg Low Titer Performance   Panel21 x 1.5 mLCE Mark Not Required
0805-0186PHA207-1.5HBsAg Mixed Titer Performance   Panel21 x 1.5 mLCE Mark Not Required
0805-0196PHG203(M2)-1.5anti-HBc/HBs Mixed Titer   Performance Panel11 x 1.5 mLCE Mark Not Required
0820-0167PHT202-1.2anti-HAV Mixed Titer Performance   Panel25 x 1.2 mLCE Mark Not Required
0810-0140PHV106(M)-1.0anti-HCV Low Titer Performance   Panel14 x 1.0 mLCE Mark Not Required
0810-0144PHV207-1.0anti-HCV Mixed Titer Performance   Panel25 x 1.0 mLCE Mark Not Required
0805-0192PHE203-1.0anti-HBc Mixed Titer Performance   Panel25 x 1.0 mLCE Mark Not Required
0610-0229PHW204-1.2HCV RNA Genotype Performance Panel10 x 1.2 mLCE Mark Not Required
0805-0198WWHD301-1.2WW HBV DNA Genotype Performance   Panel20 x 1.2 mLCE Mark Not Required


ToRCH Performance Panels


0815-0004PTT202-1.2Toxoplasma gondii Mixed Titer   Performance Panel 21 x 1.2 mLCE Mark Not Required
0815-0002PTC203-2.1Mixed Titer CMV Performance   Panel21 x 1.2 mLCE Mark Not Required
0815-0003PTH202-1.2anti-HSV 1/2 Mixed Titer   Performance Panel21 x 1.2 mLCE Mark Not Required
0820-0184PTR201-00-0.5anti-Rubella Mixed Titer   Performance Panel25 x 0.5 mLCE Mark Not Required


Other   Performance Panels








0850-0024PME202-1.2Anti-EBV Mixed Tioter   Performance Panel21 x 1.2 mLCE Mark Not Required
0820-0173PMT204-1.2anti-Trypanosoma cruzi (Chagas)   Performance Panel21 x 1.2 mLCE Mark Not Required
0820-0178PRP208-1.2anti-HTLV I/II Mixed Titer   Performance Panel21 x 1.2 mLCE Mark Not Required
0820-0183PTL202-00-0.5Lyme (IgG and IgM) Mixed Titer   Performance Panel15 x 0.5 mLCE Mark Not Required
0845-0051PVD201(M)-1.2Anti-Dengue Mixed Titer   Performance Panel16 x 1.2 mLCE Mark Not Required
0820-0191PSS202(M2)-0.5Syphilis Mixed Titer Performance   Panel Modified 17 x 0.5 mLCE Mark Not Required
0820-0186PVP201-1.2Parvo B19 Mixed Titer   Performance Panel21 x 1.2 mLCE Mark Not Required














Accutype HIV-1 Isolates








500403 through 500447Accutype HIV-1 RNA  
    RNA Purified from HIV cultured Virus   
    (Genotypes A-H and Group O)		1 x 1.0 mLCE Mark Not Required







500448 through 500494   and 502193 through 502195Accutype HIV-1 Viral   Particle IsolatesVariesCE Mark Not Required







HIV 8E5HIV-1 8E5 / LAV Subtype BPlease inquireCE Mark Not Required

501932Accutype H1N1 Viral Research   Reagent50.0 uLCE Mark Not Required


HIV   Seroconversion Panels








0600-0203PRB914-00-1.0HIV 1 Seroconversion Panel N5 x 1.0 mLCE Mark Not Required
0600-0226PRB945-00-1.0HIV 1 Seroconversion Panel AU6 x 1.0 mLCE Mark Not Required
0600-0227PRB946-00-1.0HIV 1 Seroconversion Panel AV4 x 1.0 mLCE Mark Not Required
0600-0228PRB947-1.2HIV 1 Seroconversion Panel AW4 x 1.2 mLCE Mark Not Required
0600-0230PRB949(M)-1.0HIV 1 Seroconversion Panel AY4 x 1.0 mLCE Mark Not Required
0600-0232PRB950-00-1.0HIV 1 Seroconversion Panel AZ4 x 1.0 mLCE Mark Not Required
0600-0234PRB951-00-1.0HIV 1 Seroconversion Panel BA6 x 1.0 mLCE Mark Not Required
0600-0239PRB955-1.0HIV 1 Seroconversion Panel BE5 x 1.0 mLCE Mark Not Required
0600-0240PRB956-1.0HIV 1 Seroconversion Panel BF5 x 1.0 mLCE Mark Not Required
0600-0242PRB958-1.0HIV 1 Seroconversion Panel BH6 x 1.0 mLCE Mark Not Required
0600-0243PRB961-1.0HIV 1 Seroconversion Panel9 x 1.0 mLCE Mark Not Required
0600-0244PRB962-1.0HIV 1 Seroconversion Panel6 x 1.0 mLCE Mark Not Required
0600-0245PRB963-1.0HIV 1 Seroconversion Panel7 x 1.0 mLCE Mark Not Required
0600-0246PRB964-1.0HIV 1 Seroconversion Panel6 x 1.0 mLCE Mark Not Required
0600-0248PRB966-1.0HIV 1 Seroconversion Panel10 x 1.0 mLCE Mark Not Required
0600-0249PRB967-1.0HIV 1 Seroconversion Panel6 X 1.0 mLCE Mark Not Required
0600-0250PRB968-1.0HIV 1 Seroconversion Panel10 x 1.0 mLCE Mark Not Required
0600-0251PRB969-1.0HIV 1 Seroconversion Panel10 x 1.0 mLCE Mark Not Required
0600-0252PRB970-1.0HIV 1 Seroconversion Panel4 x 1.0 mLCE Mark Not Required
0600-0253PRB971-1.0HIV 1 Seroconversion Panel4 x 1.0 mLCE Mark Not Required
0600-0254PRB972-1.0HIV 1 Seroconversion Panel6 x 1.0 mLCE Mark Not Required
0600-0256PRB973-1.2HIV 1 Seroconversion Panel4 x 1.2 mLCE Mark Not Required
0600-0258PRB974-1.2HIV 1 Seroconversion Panel4 x 1.2 mLCE Mark Not Required
0600-0260PRB975-1.2HIV 1 Seroconversion Panel5 x 1.2 mLCE Mark Not Required
0600-0261PRB976-1.2HIV 1 Seroconversion Panel4 x 1.2 mLCE Mark Not Required
0600-0262PRB977-1.2HIV 1 Seroconversion Panel4 x 1.2 mLCE Mark Not Required
0600-0263PRB978-1.2HIV 1 Seroconversion Panel7 x 1.2 mLCE Mark Not Required














Hepatitis B Seroconversion   Panels








0605-0017PHM906-00-1.5Hepatitis B Seroconversion Panel5 x 1.5 mLCE Mark Not Required
0605-0022PHM912-00-1.5Hepatitis B Seroconversion Panel9 x 1.5 mLCE Mark Not Required
0605-0025PHM918-00-1.5Hepatitis B Seroconversion Panel3 x 1.5 mLCE Mark Not Required
0605-0026PHM921-00-1.5Hepatitis B Seroconversion Panel6 x 1.5 mLCE Mark Not Required
0605-0027PHM924-00-1.5Hepatitis B Seroconversion Panel5 x 1.5 mLCE Mark Not Required
0605-0028PHM926-00-1.5Hepatitis B Seroconversion Panel8 x 1.5 mLCE Mark Not Required
0605-0030PHM929-00-1.5Hepatitis B Seroconversion Panel9 x 1.5 mLCE Mark Not Required
0605-0033PHM934(M)-1.5Hepatitis B Seroconversion Panel5 x 1.5 mLCE Mark Not Required
0605-0038PHM936-1.5Hepatitis B Seroconversion Panel8 x 1.5 mLCE Mark Not Required
0605-0039PHM937-1.5Hepatitis B Seroconversion Panel5 x 1.5 mLCE Mark Not Required
0605-0040PHM938-1.5Hepatitis B Seroconversion Panel6 x 1.5 mLCE Mark Not Required
0605-0041PHM939-1.5Hepatitis B Seroconversion Panel5 x 1.5 mLCE Mark Not Required
0605-0059PHM940-1.5Hepatitis B Seroconversion Panel8 x 1.5 mLCE Mark Not Required
0605-0060PHM941-1.5Hepatitis B Seroconversion Panel9 x 1.5 mLCE Mark Not Required


Hepatitis C   Seroconversion Panels








0610-0206PHV911(M)-1.0Hepatitis C Seroconversion Panel4 x 1.0 mLCE Mark Not Required
0610-0207PHV912-00-1.0Hepatitis C Seroconversion Panel3 x 1.0 mLCE Mark Not Required
0610-0210PHV913-00-1.0Hepatitis C Seroconversion Panel4 x 1.0 mLCE Mark Not Required
0610-0211PHV914-00-1.0Hepatitis C Seroconversion Panel9 x 1.0 mLCE Mark Not Required
0610-0212PHV915-00-1.0Hepatitis C Seroconversion Panel4 x 1.0 mLCE Mark Not Required
0610-0214PHV917-1.0(M)Hepatitis C Seroconversion Panel9 x 1.0 mLCE Mark Not Required
0610-0215PHV918(M) -1.0Hepatitis C Seroconversion Panel7 x 1.0 mLCE Mark Not Required
0610-0217PHV919-1.0Hepatitis C Seroconversion Panel7 x 1.0 mLCE Mark Not Required
0610-0218PHV920(M)-1.0Hepatitis C Seroconversion Panel9 X 1.0 mLCE Mark Not Required
0610-0220PHV921-1.0Hepatitis C Seroconversion Panel11 x 1.0 mLCE Mark Not Required
0610-0221PHV922-1.2Hepatitis C Seroconversion Panel6 x 1.2 mLCE Mark Not Required
0610-0222PHV923-1.2Hepatitis C Seroconversion Panel6 x 1.2 mLCE Mark Not Required
0610-0223PHV924-1.2Hepatitis C Seroconversion Panel6 x 1.2 mLCE Mark Not Required
0610-0224PHV925-1.2Hepatitis C Seroconversion Panel5 x 1.2 mLCE Mark Not Required
0610-0225PHV926-1.2Hepatitis C Seroconversion Panel5 x 1.2 mLCE Mark Not Required
0610-0293PHV927-1.2Hepatitis C Seroconversion Panel5 x 1.2 mLCE Mark Not Required
0610-0294PHV928-1.2Hepatitis C Seroconversion Panel9 X 1.2 mLCE Mark Not Required
0610-0295PHV929-1.2Hepatitis C Seroconversion Panel6 x 1.2 mLCE Mark Not Required


Other Seroconversion Panels








0820-0187PWN901-1.5West Nile Virus Seroconversion   Panel5 x 1.5 mLCE Mark Not Required
0615-0017PSS901-1.2Syphilis Seroconversion   Panel 9 X 1.2 mLCE Mark Not Required
0615-0016PHT903-1.0Hepatitis A Seroconversion Panel10 x 1.0 mLCE Mark Not Required


Sensitivity /   Linearity Panels








2410-0174
CMV DNA Linearity Panel9 x 2.0 mLCE Mark Not Required
2410-0162PHD802-1.2HBV DNA Linearity Panel9 x 1.2 mLCE Mark Not Required
2410-0166PHW805-1.2HCV RNA Linearity Panel8 x 1.2 mLCE Mark Not Required
2410-0170PRD802-3.5HIV-1 RNA Linearity Panel8 x 3.5 mLCE Mark Not Required

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【公司名称】 广州健仑生物科技有限公司

【市场部】 13802525278   020-82574011   杨永汉

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【公司地址】 广州市清华科技园创新基地番禺石楼镇创启路63号二期2幢101-103室


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