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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 4 of 5

Device	Model / Reference	Registries	Class	Status
Insulin（INS）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	100 Tests/kit（DR1009-2）	EUDAMED	IVD General	Active
Thyroid-stimulating Hormone（TSH） Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1001-2）	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	ZD001	EUDAMED	Class A	Active
Insulin-like Growth Factors-I (IGF-I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1112-3）	EUDAMED	IVD General	Active
C-Peptide（C-P）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	200 Tests/kit（DR1008-3）	EUDAMED	IVD General	Active
Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1159-3）	EUDAMED	IVD General	Active
Anti-Cardiolipin antibody (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1138-2）	EUDAMED	IVD General	Active
Total Triiodothyronine （TT3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1002-2）	EUDAMED	IVD General	Active
Interleukin-6（IL-6）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1121-1）	EUDAMED	IVD General	Active
Ferritin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1018-3）	EUDAMED	IVD General	Active
Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1122-1）	EUDAMED	IVD General	Active
Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1139-2）	EUDAMED	IVD General	Active
Insulin（INS）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	200 Tests/kit（DR1009-3）	EUDAMED	IVD General	Active
Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1137-1）	EUDAMED	IVD General	Active
Total Thyroxine（TT4）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1003-1）	EUDAMED	IVD General	Active
Pepsinogen I (PG I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1100-1）	EUDAMED	IVD General	Active
Anti-Müllerian Hormone (AMH) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1114-2）	EUDAMED	IVD General	Active
Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1137-2）	EUDAMED	IVD General	Active
Total PI Noncollagenous Proteins（PINP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1120-1）	EUDAMED	IVD General	Active
Hyaluronic Acid（HA）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1075-2）	EUDAMED	IVD General	Active
Immunoglobulin E (IgE) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1139-1）	EUDAMED	IVD General	Active
Angiotensin II (AII) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1118-3）	EUDAMED	IVD General	Active
Thyroid-stimulating Hormone（TSH） Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1001-3）	EUDAMED	IVD General	Active
Vitamin B12（VB12）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1084-3）	EUDAMED	IVD General	Active
Vitamin B12（VB12）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1084-1）	EUDAMED	IVD General	Active
C-Peptide（C-P）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1008-1）	EUDAMED	IVD General	Active
Vitamin B12（VB12）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1084-2）	EUDAMED	IVD General	Active
Interleukin-6（IL-6）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1121-2）	EUDAMED	IVD General	Active
Ferritin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1018-2）	EUDAMED	IVD General	Active
Folate（FA）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1085-1）	EUDAMED	IVD General	Active
Pepsinogen I (PG I) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1100-2）	EUDAMED	IVD General	Active
Automatic Chemiluminescence Immunoassay System	ZD002	EUDAMED	Class A	Active
Pepsinogen II (PG II) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1111-1）	EUDAMED	IVD General	Active
Total PI Noncollagenous Proteins（PINP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1120-2）	EUDAMED	IVD General	Active
Human Growth Hormone（GH）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	100 Tests/kit（DR1113-2）	EUDAMED	IVD General	Active
Anti-human Thyroid Peroxidase Antibody（TPOAb）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1007-1）	EUDAMED	IVD General	Active
Free Thyroxine（FT4）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1005-2）	EUDAMED	IVD General	Active
Thyroglobulin Antibody（TGAb）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	200 Tests/kit（DR1006-3）	EUDAMED	IVD General	Active
Anti-cyclic Citrullinated Peptide（Anti-CCP）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1088-1）	EUDAMED	IVD General	Active
Laminin（LN）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	100 Tests/kit（DR1074-2）	EUDAMED	IVD General	Active
Free Triiodothyronine（FT3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1004-3）	EUDAMED	IVD General	Active
Total Triiodothyronine （TT3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1002-3）	EUDAMED	IVD General	Active
Insulin（INS）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	50 Tests/kit（DR1009-1）	EUDAMED	IVD General	Active
Swab	ZD003	EUDAMED	Class I	Active
Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1158-3）	EUDAMED	IVD General	Active
Prostatic Acid Phosphatase (PAP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1157-1）	EUDAMED	IVD General	Active
Free Human Chorionic Gonadotropin β Subunit（Free-β-HCG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)	200 Tests/kit（DR1123-3）	EUDAMED	IVD General	Active
Aldosterone（ALD）Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）	200 Tests/kit（DR1081-3）	EUDAMED	IVD General	Active
Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay）	50 Tests/kit（DR1140-1）	EUDAMED	IVD General	Active
Anti-Cardiolipin antibody (Anti-CLP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）	50 Tests/kit（DR1138-1）	EUDAMED	IVD General	Active

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