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Biobase Diagnostic Technology (Shandong) Co., Ltd.

China·CN-MF-000025964

Last updated June 8, 2026

Information

Country: China
Address: 909#, Office Building, Xiaoya Industrial Park, No.51 South Gongye Road, High-tech District, Jinan, China
Website: qq.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Chuanyou Zhang
EUDAMED SRN: CN-MF-000025964
FDA FEI Number: —
DUNS Number: —

Catalogue (229)

Page 2 of 5

Device	Model / Reference	Registries	Class	Status
Carbohydrate Antigen 50（CA50）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1094-1）	EUDAMED	IVD General	Active
Follicle-stimulating Hormone（FSH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	200 Tests/kit（DR1024-3）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Prolactin（PRL）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1025-1）	EUDAMED	IVD General	Active
Automatic Chemiluminescence Immunoassay Analyzer	BKI4200	EUDAMED	Class A	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Calcitonin（CT）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1119-3）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Carbohydrate Antigen 242（CA242）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1093-2）	EUDAMED	IVD General	Active
Carbohydrate Antigen 125（CA125）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1013-3）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Cytokeratin-19-fragment (CYFRA21-1) Detection Kit（Magnetic Solid Phase Chemiluminescent）	50 Tests/kit（DR1096-1）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Luteinizing Hormone（LH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	100 Tests/kit（DR1026-2）	EUDAMED	IVD General	Active
Carbohydrate Antigen 242（CA242）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1093-3）	EUDAMED	IVD General	Active
Sex Hormone-binding Globulin（SHBG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1115-3）	EUDAMED	IVD General	Active
Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1095-2）	EUDAMED	IVD General	Active
Bone Gamma-carboxyglutamic-acid-containing Proteins (BGP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	100 Tests/kit（DR1086-2）	EUDAMED	IVD General	Active
Myoglobin（MYO）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1090-1）	EUDAMED	IVD General	Active
Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1073-1）	EUDAMED	IVD General	Active
Cleaning Liquid	DR1101	EUDAMED	Class A	Active
Cleaning Liquid	DR1101	EUDAMED	Class A	Active
Biobase COVID-19 Antigen Rapid Test	20 Tests/kit（DR1138-5）	EUDAMED	IVD General	Active
Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent）	50 Tests/kit（DR1098-1）	EUDAMED	IVD General	Active
Luteinizing Hormone（LH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	200 Tests/kit（DR1026-3）	EUDAMED	IVD General	Active
Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent）	100 Tests/kit（DR1098-2）	EUDAMED	IVD General	Active
Substrate Liquid	DR1103	EUDAMED	Class A	Active
Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1016-1）	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9（CA19-9）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1015-1）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Carbohydrate Antigen 242（CA242）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1093-1）	EUDAMED	IVD General	Active
Progesterone（P）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1029-2）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1016-3）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Testosterone（T）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1030-1）	EUDAMED	IVD General	Active
Carbohydrate Antigen 50（CA50）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1094-2）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1095-3）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Follicle-stimulating Hormone（FSH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	100 Tests/kit（DR1024-2）	EUDAMED	IVD General	Active
Carcinoembryonic Antigen（CEA）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1010-1）	EUDAMED	IVD General	Active
Dehydroepiandrosterone Sulfate（DHEA-S）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1116-2）	EUDAMED	IVD General	Active
Testosterone（T）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	100 Tests/kit（DR1030-2）	EUDAMED	IVD General	Active
N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1076-3）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Bone Gamma-carboxyglutamic-acid-containing Proteins (BGP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1086-1）	EUDAMED	IVD General	Active
Pro-gastrin-releasing Peptide（proGRP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay ）	200 Tests/kit（DR1099-3）	EUDAMED	IVD General	Active

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