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质控品

品牌：SeraCare

产地：美国

货号：01P336

发布日期： 2017-06-01
更新日期： 2022-05-05

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产地	美国
品牌	SeraCare
货号	01P336
保存条件	2-8度
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。

	ACCURUN Controls

SAP Code	Part Code	Description	# Vials x Fill Size	CE Status
		ACCURUN eQuality Software, Peer Review, and support

2205-0001	900400	Daily QC-	One License/ Computer/year
2205-0002	900401	Expert QC-	One License/ Computer/year
	900402	PC Communicator-	One License/ Computer/year
2205-0003	900403	Peer Review-	One platform/month
	900404	On-line training	1 instance
	900405	On-site training	1 instance
	900406	Network setup	1 network
		ACCURUN 1 Multi-Analyte Positive Controls

2000-0001	A001-2408-P	ACCURUN 1 Series 2400	12 x 3.5 mL	CE Marked
2000-0002	A001-2508-P	ACCURUN 1 Series 2500	12 x 3.5 mL	CE Marked
2000-0003	A001-2603-P	ACCURUN 1 Series 2600	3 x 5.0 mL	CE Marked
2000-0005	A001-2705-P	ACCURUN 1 Series 2700	6 x 3.5 mL	CE Marked
2000-0006	A001-2706-P	ACCURUN 1 Series 2700	3 x 1.0 mL	CE Marked
2000-0007	A001-3003-P	ACCURUN 1 Series 3000	3 x 5.0 mL	CE Marked
2000-0008	A001-4003-P	ACCURUN 1 Series 4000	3 x 5.0 mL	CE Marked
2000-0009	A001-4103-P	ACCURUN 1 Series 4100	3 x 5.0 mL	CE Marked
2000-0010	A001-4408-P	ACCURUN 1 Series 4400	12 x 3.5 mL	CE Marked
2000-0016	A001-5103-P	ACCURUN 1 Series 5100	3 x 5.0 mL	CE Marked
2000-0017	A001-5108-P	ACCURUN 1 Series 5100	12 x 3.5 mL	CE Marked
2000-0018	A001-5605-P	ACCURUN 1 series 5600	6 x 3.5 mL	CE Marked
2000-0022	A001-8103-P	ACCURUN 1 Series 8100	3 x 5.0 mL	CE Marked
		ACCURUN 1 Multi-Analyte Negative Controls

2010-0013	A001-1001-N	ACCURUN 1 Multi-Analyte Negative Control	1 x 5.0 mL	CE Marked
2010-0015	A001-1008-N	ACCURUN 1 Multi-Analyte Negative Control	12 x 3.5 mL	CE Marked
		ACCURUN Multi-Analyte Positive Controls

2000-0028	A21-1005-E	ACCURUN 21 Multi-Analyte Positive Control (For users of Bayer ADVIA Centaur)	6 x 3.5 mL	CE Marked
2000-0031	A21-2005-E	ACCURUN 21 Multi-Analyte Positive Control (For users of Ortho Vitros ECI)	6 x 3.5 mL	CE Marked
2000-0027	A21-1005	ACCURUN 21 Multi-Analyte Positive Control (For users of Bayer ADVIA Centaur)	6 x 3.5 mL	Not CE Marked
2000-0030	A21-2005	ACCURUN 21 Multi-Analyte Positive Control (For users of Ortho Vitros ECI)	6 x 3.5 mL	Not CE Marked
2000-0032	A24-5006	ACCURUN 24 Confirmatory Control (Anti-HIV 1/2, Anti-HTLV I, Anti-HCV)	3 x 1.0 mL	Not CE Marked
2000-0034	A25-5006	ACCURUN 25 ToRCH IgG Positive Control	3 x 1.0 mL	CE Marked
2000-0035	A26-5006	ACCURUN 26 ToRC IgM Positive Control	3 x 1.0 mL	CE Marked
2000-0039	A40-5006	ACCURUN 40 (Anti-Measles, Anti-Mumps, Anti-Rubella, Anti-VZV) Multi-Analyte Positive Control	3 x 1.0 mL	CE Marked
2000-0040	A51-5001	ACCURUN 51 Multi-Marker Hepatitis Positive Control 1	1 x 5.0 mL	CE Marked
2000-0041	A51-5005	ACCURUN 51 Multi-Marker Hepatitis Positive Control 2	6 x 3.5 mL	CE Marked
2000-0043	A52-5005	ACCURUN 52 Multi-Marker Hepatitis Positive Control 2	6 x 3.5 mL	CE Marked
		ACCURUN Multi-Analyte Negative Controls

2010-0018	A800-0004	ACCURUN 800 ToRCH Serology Negative Control	1 x 1.0 mL	CE Marked
2035-0007	A803-0027	ACCURUN 803 Nucleic Acid Negative Control	10 x 1.2 mL	CE Marked
2010-0020	A810-0005	ACCURUN 810 Multi-Analyte Serology Negative Control	6 x 3.5 mL	CE Marked
		ACCURUN Single-Analyte Positive Controls

2015-0065	A106-1003	ACCURUN 106 HIV-1 Antigen Positive Control	3 x 5.0 mL	CE Marked
2015-0066	A106-1008	ACCURUN 106 HIV-1 Antigen Positive Control	12 x 3.5 mL	CE Marked
2015-0067	A110-5001	ACCURUN 110 HBsAg Positive Control	1 x 5.0 mL	CE Marked
2015-0068	A113-5001	ACCURUN 113 HBc IgM Positive Control	1 x 5.0 mL	CE Marked
2015-0069	A113-5005	ACCURUN 113 HBc IgM Positive Control	6 x 3.5 mL	CE Marked
2015-0070	A115-5001	ACCURUN 115 HBc IgG Positive Control	1 x 5.0 mL	CE Marked
2015-0071	A117-5001	ACCURUN 117 HBeAg Positive Control	1 x 5.0 mL	CE Marked
2015-0072	A119-5001	ACCURUN 119 anti-HBe Positive Control	1 x 5.0 mL	CE Marked
2015-0073	A120-5001	ACCURUN 120 anti-HAV IgG Positive Control	1 x 5.0 mL	CE Marked
2015-0074	A121-5001	ACCURUN 121 anti-HAV IgM Positive Control	1 x 5.0 mL	CE Marked
2015-0076	A121-5005	ACCURUN 121 anti-HAV IgM Positive Control	6 x 3.5 mL	CE Marked
2015-0077	A125-5001	ACCURUN 125 anti-HBs Positive Control	1 x 5.0 mL	CE Marked
2015-0078	A125-5005	ACCURUN 125 anti-HBs Positive Control	6 x 3.5 mL	CE Marked
2015-0079	A127-5004	ACCURUN 127 Anti-Hepatitis Delta Positive Control	1 x 1.0 mL	CE Marked
2015-0080	A130-5004	ACCURUN 130 Lyme IgG EIA Positive Control	1 x 1.0 mL	CE Marked
2015-0081	A132-5004	ACCURUN 132 Lyme IgM EIA Positive Control	1 x 1.0 mL	CE Marked
2015-0082	A135-5004	ACCURUN 135 Toxo IgG Positive Control	1 x 1.0 mL	CE Marked
2015-0083	A136-5004	ACCURUN 136 Toxo IgM Positive Control	1 x 1.0 mL	CE Marked
2015-0084	A140-5001	ACCURUN 140 Rubella IgG Positive Control	1 x 5.0 mL	CE Marked
2015-0086	A141-5004	ACCURUN 141 Rubella IgM Positive Control	1 x 1.0 mL	CE Marked
2015-0087	A145-5004	ACCURUN 145 CMV IgG Positive Control	1 x 1.0 mL	CE Marked
2015-0088	A146-5004	ACCURUN 146 CMV IgM Positive Control	1 x 1.0 mL	CE Marked
2015-0089	A150-5004	ACCURUN 150 HSV IgG Positive Control	1 x 1.0 mL	CE Marked
2015-0090	A155-2010	ACCURUN 155 Series 2000 Syphilis (ATA) Positive Control	3 x 2.0 mL	CE Marked
2015-0092	A155-5008	ACCURUN 155 Series 5000 Syphilis (ATA) Positive Control	12 x 3.5 mL	CE Marked
2015-0093	A155-5010	ACCURUN 155 Series 5000 Syphilis (ATA) Positive Control	3 x 2.0 mL	CE Marked
2015-0094	A156-5006	ACCURUN 156 Syphilis (RPR) Positive Control	3 x 1.0 mL	CE Marked
2015-0095	A165-5118	ACCURUN 165 WNV IgG / IgM Positive Control	3 x 0.25 mL	Not CE Marked
2000-0037	A30-5006	ACCURUN 30 EBV IgG Positive Control	3 x 1.0 mL	CE Marked
2000-0038	A31-5006	ACCURUN 31 EBV IgM Positive Control	3 x 1.0 mL	CE Marked
2015-0097	A190-5005	ACCURN 190 Anti-Trypanosoma Cruzi (Chagas) Positive Control	6 x 3.5 mL	CE Marked
		ACCURUN Single-Analyte Molecular Controls

2020-0080	A305-6124	ACCURUN 305 Series 100 HCV RNA Control	5 x 1.0 mL	CE Marked
2020-0078	A305-2127	ACCURUN 305 Series 150 HCV RNA Control	10 x 1.0 mL	CE Marked
2020-0079	A305-2132	ACCURUN 305 Series 150 HCV RNA Control	5 x 4.0 mL	CE Marked
2020-0081	A305-6224	ACCURUN 305 Series 200 HCV RNA Control	5 x 1.0 mL	CE Marked
2020-0082	A305-6232	ACCURUN 305 Series 200 HCV RNA Control	5 x 4.0 mL	CE Marked
2020-0083	A305-6324	ACCURUN 305 Series 300 HCV RNA Control	5 x 1.0 mL	CE Marked
2020-0085	A305-6432	ACCURUN 305 Series 400 HCV RNA Control	5 x 4.0 mL	CE Marked
2020-0086	A306-6515	ACCURUN 306 Series 500 HCV RNA Control	10 x 0.5 mL	Not CE Marked
2020-0087	A315-2127	ACCURUN 315 Series 150 HIV RNA Control	10 x 1.2 mL	CE Marked
2020-0090	A315-5224	ACCURUN 315 Series 200 HIV RNA Control	5 x 1.0 mL	CE Marked
2020-0091	A315-5332	ACCURUN 315 Series 300 HIV RNA Control	5 x 4.0 mL	CE Marked
2020-0092	A315-5424	ACCURUN 315 Series 400 HIV RNA Control	5 x 1.0 mL	CE Marked
2020-0093	A315-5524	ACCURUN 315 Series 500 HIV RNA Control	5 x 1.0 mL	CE Marked
2020-0094	A315-5532	ACCURUN 315 Series 500 HIV RNA Control	5 x 4.0 mL	CE Marked
2020-0096	A325-5232	ACCURUN 325 Series 200 HBV DNA Control	5 x 4.0 mL	CE Marked
2020-0095	A325-3734	ACCURUN 325 Series 370 HBV DNA Control	5 x 0.6 mL	Not CE Marked
2020-0098	A325-5732	ACCURUN 325 Series 700 HBV DNA Control	5 x 4.0 mL	CE Marked
2020-0099	A341-5132	ACCURUN 341 series 100 CtNg Positive Control	5 x 4.0 mL	Not CE Marked
2020-0100	A341-5132-E	ACCURUN 341 series 100 CtNg Positive Control	5 x 4.0 mL	CE Marked
2020-0102	A341-5724	ACCURUN 341 series 700 CtNg Positive Control	5 x 1.0 mL	Not CE Marked
2020-0103	A341-5724-E	ACCURUN 341 series 700 CtNg Positive Control	5 x 1.0 mL	CE Marked
2020-0104	A345-2124	ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Multi-Analyte Positive Control	5 x 1.0 mL	CE Marked
2020-0105	A345-2132	ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Multi-Analyte Positive Control	5 x 4.0 mL	CE Marked
2020-0106	A350-5334	ACCURUN 350 Series 300 CMV DNA Positive Control	5 x 0.75 mL	Not CE Marked
2020-0107	A365-5228	ACCURUN 365 Series 200 Lineage 1 WNV RNA Positive Control	10 x 1.5 mL	Not CE Marked
2025-0036	A372-4034	ACCURUN 372 HPV DNA Positive Control, Series 400	10 x 0.8 mL cell 10 x 2.0 mL diluent	Not CE Marked
2025-0037	A372-4034-E	ACCURUN 372 HPV DNA Positive Control, Series 400	10 x 0.8 mL cell 10 x 2.0 mL diluent	CE Marked
2025-0042	A372-5627-P	ACCURUN 372 HPV DNA Positive Control, Series 600	10 x 0.8 mL cell 10 x 2.0 mL diluent	Not CE Marked
2025-0041	A372-5627-E	ACCURUN 372 HPV DNA Positive Control, Series 600	10 x 0.8 mL cell 10 x 2.0 mL diluent	CE Marked
2025-0043	A378-5030	ACCURUN 378 HPV DNA Positive Control, Series 5000	20 x 4.0 mL	CE Marked
	A865-5228	ACCURUN 865 WNV RNA Negative Control	10 x 1.5 mL	Not CE Marked
2035-0004	A872-5027-N	ACCURUN 872 HPV DNA Negative Control	10 x 1.0 mL cell suspension 10 x 1.0 mL diluent	Not CE Marked
2035-0009	A872-5027-E	ACCURUN 872 HPV DNA Negative Control	10 x 1.0 mL cell suspension 10 x 1.0 mL diluent	CE Marked
2035-0005	A873-5030-N	ACCURUN 873 HPV DNA Negative Control	10 x 1.0 mL cell suspension 10 x 1.0 mL diluent	CE Marked

		ACCURUN Genetic Controls
2040-0010	A632-1039-P	ACCURUN 632 Cystic Fibrosis 32 Control	1 x 15 μL	Not CE Marked
2040-0011	A632-1040-P	ACCURUN 632 Cystic Fibrosis 32 Control	1 x 100 μL	Not CE Marked
2040-0014	A644-1040-E	ACCURUN 644 Cystic Fibrosis 40+4 Control	1 x 100 μL	CE Marked
2040-0015	A644-1040-P	ACCURUN 644 Cystic Fibrosis 40+4 Control	1 x 100 μL	Not CE Marked
2040-0009	A676-1040-P	ACCURUN 676 Cystic Fibrosis Extended Control	1 x 100 μL	Not CE Marked

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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

【公司传真】 020-32206070

【腾讯 QQ】 2042552662

【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