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Genobio Pharmaceutical Co., Ltd.

China·CN-MF-000027997

Last updated September 17, 2026

About

Our Group Companies Era Biology Group operates through a network of wholly owned subsidiaries to serve customers worldwide: • Beijing Gold Mountainriver Tech Development Co., Ltd. • Genobio Pharmaceutical Co., Ltd. • Beihai Sinlon Co., Ltd. • Era Biology (Shanghai) Co., Ltd. • Era Biology (Guangzhou) Co., Ltd. • Era Biology (Suzhou) Co., Ltd. • Era Biology (Canada) Co. Ltd.

From the manufacturer's own website, in their original language. Source

Information

Country: China
Address: 2-1, 2, 3-101, No.2 Zone, Binlv Industrial Park, Binhai Tourism Area, Binhai New Area, Tianjin, China
Website: www.era-bio.com
LinkedIn: linkedin.com/company/tianjin-era-biology-co-ltd/about
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yanbin Huang
EUDAMED SRN: CN-MF-000027997
FDA FEI Number: 3014655875
DUNS Number: —

Catalogue (34)

Device	Model / Reference	Registries	Class	Status
Candida Mannan Detection Kit (CLIA)	MNCLIA-01	EUDAMED	IVD General	Active
Aspergillus Galactomannan Detection Kit (CLIA)	GMCLIA-01	EUDAMED	IVD General	Active
Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)	GXM-01	EUDAMED	IVD General	Active
Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)	GXM-02	EUDAMED	IVD General	Active
Aspergillus Galactomannan Detection K-Set (Lateral Flow Assay)	GMLFA-01	EUDAMED	IVD General	Active
Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay)	CP5-01	EUDAMED	IVD General	Active
Aspergillus IgG Antibody Detection Kit (CLIA)	AGCLIA-01	EUDAMED	IVD General	Active
Monkeypox Virus Molecular Detection Kit (Real-time PCR)	MXVPCR-50	EUDAMED	IVD General	Active
Bacterial Endotoxin Detection Kit (CLIA)	BECLIA-01	EUDAMED	IVD General	Active
Mucorales Molecular Detection Kit (Real-time PCR)	FMPCR-50	EUDAMED	IVD General	Active
Aspergillus Galactomanan ELISA Detection Kit	GMKT-01	EUDAMED	IVD General	Active
Cryptococcal Capsular Polysaccharide Detection Kit (CLIA)	GXMCLIA-01	EUDAMED	IVD General	Active
Procalcitonin (PCT) Detection Kit (CLIA)	PCTCLIA-01	EUDAMED	IVD General	Active
Aspergillus Molecular Detection Kit (Real-time PCR)	FAPCR-50	EUDAMED	IVD General	Active
Fungus (1-3)-β-D-Glucan Detection Kit (CLIA)	BGCLIA-01	EUDAMED	IVD General	Active
Mucorales Molecular Detection Kit (Real-time PCR)	FMPCR-20	EUDAMED	IVD General	Active
Cryptococcus Molecular Detection Kit (Real-time PCR)	FCPCR-25	EUDAMED	IVD General	Active
Talaromyces marneffei Molecular Detection Kit (Real-time PCR)	FTMPCR-25	EUDAMED	IVD General	Active
Cryptococcus Molecular Detection Kit (Real-time PCR)	FCPCR-50	EUDAMED	IVD General	Active
Full-Automatic Chemiluminescence Immunoassay System	FACIS-I	EUDAMED	Class A	Active
Candida Mannan IgG Antibody Detection K-Set(CLIA)	CGCLIA-01	EUDAMED	IVD General	Active
Aspergillus IgM Antibody Detection K-Set(CLIA)	AMCLIA-01	EUDAMED	IVD General	Active
Pneumocystis Molecular Detection Kit (Real-time PCR)	FPPCR-25	EUDAMED	IVD General	Active
Fully Automatic Kinetic Tube Reader	IGL-200	EUDAMED	Class A	Active
C Reactive Protein (CRP) Detection Kit (CLIA)	CRPCLIA-01	EUDAMED	IVD General	Active
Candida auris Molecular Detection Kit (Real-time PCR)	FCUPCR-25	EUDAMED	IVD General	Active
Candida auris Molecular Detection Kit (Real-time PCR)	FCUPCR-50	EUDAMED	IVD General	Active
Candida Mannan IgM Antibody Detection K-Set(CLIA)	CMCLIA-01	EUDAMED	IVD General	Active
Heparin Binding Protein (HBP) Detection Kit (CLIA)	HBPCLIA-01	EUDAMED	IVD General	Active
Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time PCR)	FPCR-50	EUDAMED	IVD General	Active
Talaromyces marneffei Molecular Detection Kit (Real-time PCR)	FTMPCR-50	EUDAMED	IVD General	Active
Immunochromatography Analyzer	GIC-H1W	EUDAMED	Class A	Active
MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography)	MCR-01	EUDAMED	IVD General	Active
Influenza A&B Antigen Rapid Test (Colloidal Gold)	VILFA-01	EUDAMED	IVD General	Active

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