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Qualification Panels

2017-06-01

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简介

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 Code	Part Code	Description	# Vials x Fill Size	CE Status
		Qualification Panels

2400-0140	QCA702-4.0	HIV RNA / HCV/HBV DNA RNA Qualification Panel	5 x 4.0 mL	CE Mark Not Required
2400-0141	QHA711-2.0	HBsAg Qualification Panel	6 x 2.0 mL	CE Mark Not Required
2400-0145	QHG711-2.0	anti-HBc Qualification Panel	6 x 2.0 mL	CE Mark Not Required
2400-0148	QHV712-1.0	anti-HCV Qualification Panel Level 2	6 x 1.0 mL	CE Mark Not Required
2400-0181	QRP713-1.5	anti-HTLV I/II Qualification Panel	6 x 1.5 mL	CE Mark Not Required
2400-0158	QRX701-3.5	HIV 1/2/O/p24 Qualification Panel	6 x 3.5 mL	CE Mark Not Required
2400-0160	QRZ761-1.0	anti-HIV-1/2 Qualification Panel	6 x 1.0 mL	CE Mark Not Required
2400-0161	QSH701-4.0	HPV Qualification Panel	25 x 4.0 mL	CE Mark Not Required
2400-0163	QSS701-2.0	Syphilis Qualification Panel	6 x 2.0 mL	CE Mark Not Required
2400-0164	QTC711-3.0	anti-CMV Qualification Panel	6 x 3.0 mL	CE Mark Not Required
		Basematrix

1805-0074	B001-0008	Basematrix	12 x 3.5 mL	CE Mark Not Required
1805-0075	501101	Basematrix 53	1 x 1 Liter	CE Mark Not Required
		HIV Performance Panels

0800-0238	PRA204-1.5	HIV p24 Antigen Mixed Titer Performance Panel	25 x 1.5 mL	CE Mark Not Required
0800-0237	PRA204(B)-1.5	HIV p24 Antigen Mixed Titer Performance Panel	12 x 1.5mL	CE Mark Not Required
0800-0241	PRB109-1.0	anti-HIV 1 Low Titer Performance Panel	20 x 1.0 mL	CE Mark Not Required
0800-0246	PRB205(M)-1.0	anti-HIV-1 Mixed Titer Performance Panel	24 X 1.0 mL	CE Mark Not Required
0800-0248	PRB601-1.0	HIV-1 Incidence/Prevalence Performance Panel	15 x 1.0 mL	CE Mark Not Required
0800-0249	PRD201-1.2	HIV 1 Genotype Performance Panel	9 x 1.2 mL	CE Mark Not Required
0800-0250	PRD202-1.1	HIV RNA Genotype Performance Panel	10 x 1.1 mL	CE Mark Not Required
0800-0251	PRD250-1.0	Teragenix HIV Drug Resistance Performance Panel	10 x 1.0 mL	CE Mark Not Required
0800-0255	PRF203-1.0	HIV-2 Mixed Titer Performance Panel	11 x 1.0 mL	CE Mark Not Required
0800-0261	PRZ208-0.25	anti-HIV-1/2 Combo Performance Panel	15 x 0.25 mL	CE Mark Not Required
0800-0235	WWRB305-0.5	WW HIV Performance Panel	20 x 0.5 mL	CE Mark Not Required
		Hepatitis Performance Panels

0805-0183	PHA107-1.5	HBsAg Low Titer Performance Panel	21 x 1.5 mL	CE Mark Not Required
0805-0186	PHA207-1.5	HBsAg Mixed Titer Performance Panel	21 x 1.5 mL	CE Mark Not Required
0805-0196	PHG203(M2)-1.5	anti-HBc/HBs Mixed Titer Performance Panel	11 x 1.5 mL	CE Mark Not Required
0820-0167	PHT202-1.2	anti-HAV Mixed Titer Performance Panel	25 x 1.2 mL	CE Mark Not Required
0810-0140	PHV106(M)-1.0	anti-HCV Low Titer Performance Panel	14 x 1.0 mL	CE Mark Not Required
0810-0144	PHV207-1.0	anti-HCV Mixed Titer Performance Panel	25 x 1.0 mL	CE Mark Not Required
0805-0192	PHE203-1.0	anti-HBc Mixed Titer Performance Panel	25 x 1.0 mL	CE Mark Not Required
0610-0229	PHW204-1.2	HCV RNA Genotype Performance Panel	10 x 1.2 mL	CE Mark Not Required
0805-0198	WWHD301-1.2	WW HBV DNA Genotype Performance Panel	20 x 1.2 mL	CE Mark Not Required
		ToRCH Performance Panels
0815-0004	PTT202-1.2	Toxoplasma gondii Mixed Titer Performance Panel	21 x 1.2 mL	CE Mark Not Required
0815-0002	PTC203-2.1	Mixed Titer CMV Performance Panel	21 x 1.2 mL	CE Mark Not Required
0815-0003	PTH202-1.2	anti-HSV 1/2 Mixed Titer Performance Panel	21 x 1.2 mL	CE Mark Not Required
0820-0184	PTR201-00-0.5	anti-Rubella Mixed Titer Performance Panel	25 x 0.5 mL	CE Mark Not Required
		Other Performance Panels

0850-0024	PME202-1.2	Anti-EBV Mixed Tioter Performance Panel	21 x 1.2 mL	CE Mark Not Required
0820-0173	PMT204-1.2	anti-Trypanosoma cruzi (Chagas) Performance Panel	21 x 1.2 mL	CE Mark Not Required
0820-0178	PRP208-1.2	anti-HTLV I/II Mixed Titer Performance Panel	21 x 1.2 mL	CE Mark Not Required
0820-0183	PTL202-00-0.5	Lyme (IgG and IgM) Mixed Titer Performance Panel	15 x 0.5 mL	CE Mark Not Required
0845-0051	PVD201(M)-1.2	Anti-Dengue Mixed Titer Performance Panel	16 x 1.2 mL	CE Mark Not Required
0820-0191	PSS202(M2)-0.5	Syphilis Mixed Titer Performance Panel Modified	17 x 0.5 mL	CE Mark Not Required
0820-0186	PVP201-1.2	Parvo B19 Mixed Titer Performance Panel	21 x 1.2 mL	CE Mark Not Required


		Accutype HIV-1 Isolates

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



	500448 through 500494 and 502193 through 502195	Accutype HIV-1 Viral Particle Isolates	Varies	CE Mark Not Required



	HIV 8E5	HIV-1 8E5 / LAV Subtype B	Please inquire	CE Mark Not Required
	501932	Accutype H1N1 Viral Research Reagent	50.0 uL	CE Mark Not Required
		HIV Seroconversion Panels

0600-0203	PRB914-00-1.0	HIV 1 Seroconversion Panel N	5 x 1.0 mL	CE Mark Not Required
0600-0226	PRB945-00-1.0	HIV 1 Seroconversion Panel AU	6 x 1.0 mL	CE Mark Not Required
0600-0227	PRB946-00-1.0	HIV 1 Seroconversion Panel AV	4 x 1.0 mL	CE Mark Not Required
0600-0228	PRB947-1.2	HIV 1 Seroconversion Panel AW	4 x 1.2 mL	CE Mark Not Required
0600-0230	PRB949(M)-1.0	HIV 1 Seroconversion Panel AY	4 x 1.0 mL	CE Mark Not Required
0600-0232	PRB950-00-1.0	HIV 1 Seroconversion Panel AZ	4 x 1.0 mL	CE Mark Not Required
0600-0234	PRB951-00-1.0	HIV 1 Seroconversion Panel BA	6 x 1.0 mL	CE Mark Not Required
0600-0239	PRB955-1.0	HIV 1 Seroconversion Panel BE	5 x 1.0 mL	CE Mark Not Required
0600-0240	PRB956-1.0	HIV 1 Seroconversion Panel BF	5 x 1.0 mL	CE Mark Not Required
0600-0242	PRB958-1.0	HIV 1 Seroconversion Panel BH	6 x 1.0 mL	CE Mark Not Required
0600-0243	PRB961-1.0	HIV 1 Seroconversion Panel	9 x 1.0 mL	CE Mark Not Required
0600-0244	PRB962-1.0	HIV 1 Seroconversion Panel	6 x 1.0 mL	CE Mark Not Required
0600-0245	PRB963-1.0	HIV 1 Seroconversion Panel	7 x 1.0 mL	CE Mark Not Required
0600-0246	PRB964-1.0	HIV 1 Seroconversion Panel	6 x 1.0 mL	CE Mark Not Required
0600-0248	PRB966-1.0	HIV 1 Seroconversion Panel	10 x 1.0 mL	CE Mark Not Required
0600-0249	PRB967-1.0	HIV 1 Seroconversion Panel	6 X 1.0 mL	CE Mark Not Required
0600-0250	PRB968-1.0	HIV 1 Seroconversion Panel	10 x 1.0 mL	CE Mark Not Required
0600-0251	PRB969-1.0	HIV 1 Seroconversion Panel	10 x 1.0 mL	CE Mark Not Required
0600-0252	PRB970-1.0	HIV 1 Seroconversion Panel	4 x 1.0 mL	CE Mark Not Required
0600-0253	PRB971-1.0	HIV 1 Seroconversion Panel	4 x 1.0 mL	CE Mark Not Required
0600-0254	PRB972-1.0	HIV 1 Seroconversion Panel	6 x 1.0 mL	CE Mark Not Required
0600-0256	PRB973-1.2	HIV 1 Seroconversion Panel	4 x 1.2 mL	CE Mark Not Required
0600-0258	PRB974-1.2	HIV 1 Seroconversion Panel	4 x 1.2 mL	CE Mark Not Required
0600-0260	PRB975-1.2	HIV 1 Seroconversion Panel	5 x 1.2 mL	CE Mark Not Required
0600-0261	PRB976-1.2	HIV 1 Seroconversion Panel	4 x 1.2 mL	CE Mark Not Required
0600-0262	PRB977-1.2	HIV 1 Seroconversion Panel	4 x 1.2 mL	CE Mark Not Required
0600-0263	PRB978-1.2	HIV 1 Seroconversion Panel	7 x 1.2 mL	CE Mark Not Required


		Hepatitis B Seroconversion Panels

0605-0017	PHM906-00-1.5	Hepatitis B Seroconversion Panel	5 x 1.5 mL	CE Mark Not Required
0605-0022	PHM912-00-1.5	Hepatitis B Seroconversion Panel	9 x 1.5 mL	CE Mark Not Required
0605-0025	PHM918-00-1.5	Hepatitis B Seroconversion Panel	3 x 1.5 mL	CE Mark Not Required
0605-0026	PHM921-00-1.5	Hepatitis B Seroconversion Panel	6 x 1.5 mL	CE Mark Not Required
0605-0027	PHM924-00-1.5	Hepatitis B Seroconversion Panel	5 x 1.5 mL	CE Mark Not Required
0605-0028	PHM926-00-1.5	Hepatitis B Seroconversion Panel	8 x 1.5 mL	CE Mark Not Required
0605-0030	PHM929-00-1.5	Hepatitis B Seroconversion Panel	9 x 1.5 mL	CE Mark Not Required
0605-0033	PHM934(M)-1.5	Hepatitis B Seroconversion Panel	5 x 1.5 mL	CE Mark Not Required
0605-0038	PHM936-1.5	Hepatitis B Seroconversion Panel	8 x 1.5 mL	CE Mark Not Required
0605-0039	PHM937-1.5	Hepatitis B Seroconversion Panel	5 x 1.5 mL	CE Mark Not Required
0605-0040	PHM938-1.5	Hepatitis B Seroconversion Panel	6 x 1.5 mL	CE Mark Not Required
0605-0041	PHM939-1.5	Hepatitis B Seroconversion Panel	5 x 1.5 mL	CE Mark Not Required
0605-0059	PHM940-1.5	Hepatitis B Seroconversion Panel	8 x 1.5 mL	CE Mark Not Required
0605-0060	PHM941-1.5	Hepatitis B Seroconversion Panel	9 x 1.5 mL	CE Mark Not Required
		Hepatitis C Seroconversion Panels

0610-0206	PHV911(M)-1.0	Hepatitis C Seroconversion Panel	4 x 1.0 mL	CE Mark Not Required
0610-0207	PHV912-00-1.0	Hepatitis C Seroconversion Panel	3 x 1.0 mL	CE Mark Not Required
0610-0210	PHV913-00-1.0	Hepatitis C Seroconversion Panel	4 x 1.0 mL	CE Mark Not Required
0610-0211	PHV914-00-1.0	Hepatitis C Seroconversion Panel	9 x 1.0 mL	CE Mark Not Required
0610-0212	PHV915-00-1.0	Hepatitis C Seroconversion Panel	4 x 1.0 mL	CE Mark Not Required
0610-0214	PHV917-1.0(M)	Hepatitis C Seroconversion Panel	9 x 1.0 mL	CE Mark Not Required
0610-0215	PHV918(M) -1.0	Hepatitis C Seroconversion Panel	7 x 1.0 mL	CE Mark Not Required
0610-0217	PHV919-1.0	Hepatitis C Seroconversion Panel	7 x 1.0 mL	CE Mark Not Required
0610-0218	PHV920(M)-1.0	Hepatitis C Seroconversion Panel	9 X 1.0 mL	CE Mark Not Required
0610-0220	PHV921-1.0	Hepatitis C Seroconversion Panel	11 x 1.0 mL	CE Mark Not Required
0610-0221	PHV922-1.2	Hepatitis C Seroconversion Panel	6 x 1.2 mL	CE Mark Not Required
0610-0222	PHV923-1.2	Hepatitis C Seroconversion Panel	6 x 1.2 mL	CE Mark Not Required
0610-0223	PHV924-1.2	Hepatitis C Seroconversion Panel	6 x 1.2 mL	CE Mark Not Required
0610-0224	PHV925-1.2	Hepatitis C Seroconversion Panel	5 x 1.2 mL	CE Mark Not Required
0610-0225	PHV926-1.2	Hepatitis C Seroconversion Panel	5 x 1.2 mL	CE Mark Not Required
0610-0293	PHV927-1.2	Hepatitis C Seroconversion Panel	5 x 1.2 mL	CE Mark Not Required
0610-0294	PHV928-1.2	Hepatitis C Seroconversion Panel	9 X 1.2 mL	CE Mark Not Required
0610-0295	PHV929-1.2	Hepatitis C Seroconversion Panel	6 x 1.2 mL	CE Mark Not Required
		Other Seroconversion Panels

0820-0187	PWN901-1.5	West Nile Virus Seroconversion Panel	5 x 1.5 mL	CE Mark Not Required
0615-0017	PSS901-1.2	Syphilis Seroconversion Panel	9 X 1.2 mL	CE Mark Not Required
0615-0016	PHT903-1.0	Hepatitis A Seroconversion Panel	10 x 1.0 mL	CE Mark Not Required
		Sensitivity / Linearity Panels

2410-0174		CMV DNA Linearity Panel	9 x 2.0 mL	CE Mark Not Required
2410-0162	PHD802-1.2	HBV DNA Linearity Panel	9 x 1.2 mL	CE Mark Not Required
2410-0166	PHW805-1.2	HCV RNA Linearity Panel	8 x 1.2 mL	CE Mark Not Required
2410-0170	PRD802-3.5	HIV-1 RNA Linearity Panel	8 x 3.5 mL	CE Mark Not Required

微信二维码，扫一扫：

【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

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联系我们

广州健仑生物科技有限公司

联系人 杨永汉
联系手机13802525278
联系电话86-020-82574011
所在地址广州清华科技园创新基地番禺区石楼镇创启路63号二期2幢101-3室

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