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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 (228)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
TSH Receptor Antibody（Anti-TSHR）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1091-3）	EUDAMED	IVD General	Active
Substrate Liquid	DR1103	EUDAMED	Class A	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Squamous Cell Carcinoma Antigen（SCC）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1097-3）	EUDAMED	IVD General	Active
Carcinoembryonic Antigen（CEA）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1010-3）	EUDAMED	IVD General	Active
Estradiol（E2）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1028-3）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Monkeypox Virus Real Time PCR Kit	50 rxns/kit（DR1160-1）	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)	200 Tests/kit（DR1086-3）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Biobase COVID-19 Antigen Rapid Test	25 Tests/kit（DR1138-6）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1014-3）	EUDAMED	IVD General	Active
Pro-gastrin-releasing Peptide（proGRP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay ）	100 Tests/kit（DR1099-2）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Thyroglobulin（TG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1083-1）	EUDAMED	IVD General	Active
Carbohydrate Antigen 125（CA125）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1013-1）	EUDAMED	IVD General	Active
Follicle-stimulating Hormone（FSH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1024-1）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Calcitonin（CT）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1119-1）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1078-1）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Automatic Chemiluminescence Immunoassay Analyzer	BKI6400	EUDAMED	Class A	Active
Progesterone（P）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1029-3）	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9（CA19-9）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1015-2）	EUDAMED	IVD General	Active
Carcinoembryonic Antigen（CEA）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1010-2）	EUDAMED	IVD General	Active
Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent）	200 Tests/kit（DR1098-3）	EUDAMED	IVD General	Active
TSH Receptor Antibody（Anti-TSHR）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1091-2）	EUDAMED	IVD General	Active
Squamous Cell Carcinoma Antigen（SCC）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	W0102030116	EUDAMED	IVD General	Active
Substrate Liquid	DR1103	EUDAMED	Class A	Active
Intact Parathyroid Hormone（iPTH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1082-1）	EUDAMED	IVD General	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Substrate Liquid	DR1103	EUDAMED	Class A	Active
Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1016-2）	EUDAMED	IVD General	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
PCR Master Mix	ZD007	EUDAMED	Class A	Active
Sample Diluent	ZD006	EUDAMED	Class A	Active
Luteinizing Hormone（LH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1026-1）	EUDAMED	IVD General	Active
Myoglobin（MYO）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1090-2）	EUDAMED	IVD General	Active
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

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