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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 3 of 5

Device	Model / Reference	Registries	Class	Status
Automatic Chemiluminescence Immunoassay Analyzer	BKI5800	EUDAMED	Class A	Active
Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1095-1）	EUDAMED	IVD General	Active
Thyroglobulin（TG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1083-2）	EUDAMED	IVD General	Active
Creatine Kinase Isoenzymes （CK-MB）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1077-2）	EUDAMED	IVD General	Active
Dehydroepiandrosterone Sulfate（DHEA-S）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1116-3）	EUDAMED	IVD General	Active
Sex Hormone-binding Globulin（SHBG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1115-1）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Myoglobin（MYO）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1090-3）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Carbohydrate Antigen 125（CA125）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1013-2）	EUDAMED	IVD General	Active
Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1078-3）	EUDAMED	IVD General	Active
Intact Parathyroid Hormone（iPTH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	W0102060312	EUDAMED	IVD General	Active
Estradiol（E2）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1028-2）	EUDAMED	IVD General	Active
Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1014-2）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Carbohydrate Antigen 72-4（CA72-4）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1092-3）	EUDAMED	IVD General	Active
Testosterone（T）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	200 Tests/kit（DR1030-3）	EUDAMED	IVD General	Active
Cleaning Liquid	DR1101	EUDAMED	Class A	Active
Carbohydrate Antigen 19-9（CA19-9）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1015-3）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Estradiol（E2）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1028-1）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Prolactin（PRL）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1025-2）	EUDAMED	IVD General	Active
TSH Receptor Antibody（Anti-TSHR）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1091-1）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Squamous Cell Carcinoma Antigen（SCC）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1097-2）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Carbohydrate Antigen 72-4（CA72-4）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1092-1）	EUDAMED	IVD General	Active
Calcitonin（CT）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1119-2）	EUDAMED	IVD General	Active
Prolactin（PRL）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1025-3）	EUDAMED	IVD General	Active
Carbohydrate Antigen 50（CA50）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1094-3）	EUDAMED	IVD General	Active
Dehydroepiandrosterone Sulfate（DHEA-S）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1116-1）	EUDAMED	IVD General	Active
Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1073-2）	EUDAMED	IVD General	Active
Pro-gastrin-releasing Peptide（proGRP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay ）	50 Tests/kit（DR1099-1）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Collagen IV（CIV）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1073-3）	EUDAMED	IVD General	Active
Sex Hormone-binding Globulin（SHBG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1115-2）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Intact Parathyroid Hormone（iPTH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1082-3）	EUDAMED	IVD General	Active
Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1078-2）	EUDAMED	IVD General	Active
Human Chorionic Gonadotropin β（β-HCG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1022-2）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Disposable Virus Sampling Tube	ZD004	EUDAMED	Class A	Active
Aldosterone（ALD）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1081-3）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Automatic Chemiluminescence Immunoassay System	ZD002	EUDAMED	Class A	Active

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