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Darui Biotechnology Co., Ltd.

China·CN-MF-000030310

Last updated June 8, 2026

Information

Country: China
Address: 6 Lizhishan Road, High & New Technology Development District, Guangzhou, Guangdong, China. 510665, Guangzhou, China
Website: 163.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Zhining Dong
EUDAMED SRN: CN-MF-000030310
FDA FEI Number: —
DUNS Number: —

Catalogue (109)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Neuron-Specific Enolase (NSE) Diagnostic Kit (TRFIA)	DR-CM-A016	EUDAMED	IVD General	Active
Thyroglobulin Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A034	EUDAMED	IVD General	Active
N-terminal Atrial Natriuretic Peptide Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A041	EUDAMED	IVD General	Active
Human β2-microglobulin Quantitative Diagnostic Kit (TRFIA)	DR-CM-A011	EUDAMED	IVD General	Active
Free Triiodothyronine (FT3) Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A038	EUDAMED	IVD General	Active
Total Triiodothyronine (TT3) Calibrator	DR-CAL-CK-A023	EUDAMED	IVD General	Active
Testosterone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-B005	EUDAMED	IVD General	Active
Ferritin Calibrator	DR-CAL-CK-A011	EUDAMED	IVD General	Active
Placental Growth Factor Calibrator	DR-CAL-CK-A017	EUDAMED	IVD General	Active
Anti-thyroglobulin Antibody Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A033	EUDAMED	IVD General	Active
D-Dimer Calibrator	DR-CAL-CK-A026	EUDAMED	IVD General	Active
Prolactin Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-B002	EUDAMED	IVD General	Active
Free Estriol Diagnostic Kit (CLIA)	DR-CLIA-CK-A028	EUDAMED	IVD General	Active
Testosterone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-A005	EUDAMED	IVD General	Active
Prolactin Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-A002	EUDAMED	IVD General	Active
Carcinoembryonic Antigen (CEA) Diagnostic Kit (TRFIA)	DR-CM-A002	EUDAMED	IVD General	Active
Pregnancy Associated Plasma Protein A Calibrator	DR-CAL-CK-A013	EUDAMED	IVD General	Active
Carbohydrate Antigen 50 (CA50) Diagnostic Kit (TRFIA)	DR-CM-A007	EUDAMED	IVD General	Active
Total Thyroxine (TT4) Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A031	EUDAMED	IVD General	Active
N-terminal Atrial Natriuretic Peptide Calibrator	DR-CAL-CK-A028	EUDAMED	IVD General	Active
Glucose-6-Phosphate Dehydrogenase (G6PD) Diagnostic Kit (Fluorometric Assay)	DR-NS-A003	EUDAMED	IVD General	Active
Cardiac Troponin I Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A043	EUDAMED	IVD General	Active
Phenylalanine (Phe) Diagnostic Kit (Fluorometric Assay)	DR-NS-A002	EUDAMED	IVD General	Active
Ferritin Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A017	EUDAMED	IVD General	Active
Progesterone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-B006	EUDAMED	IVD General	Active
Myoglobin Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A044	EUDAMED	IVD General	Active
Follicle Stimulating Hormone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-A003	EUDAMED	IVD General	Active
Schistosoma Japonicum (SJ) Diagnostic Kit (ELISA)	DR-PA-A002	EUDAMED	IVD General	Active
Free Beta-Human Chorionic Gonadotropin (β-hCG) Quantitative Diagnostic Kit (TRFIA)	DR-HO-A013	EUDAMED	IVD General	Active
Neutrophil Gelatinase-Associated Lipocalinn Calibrator	DR-CAL-CM-A033	EUDAMED	IVD General	Active
Alpha-fetoprotein Quantitative Diagnostic Kit (TRFIA )	DR-CM-A001	EUDAMED	IVD General	Active
Progesterone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-A006	EUDAMED	IVD General	Active
Cardiac Troponin I Calibrator	DR-CAL-CK-A030	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit (TRFIA)	DR-CM-A013	EUDAMED	IVD General	Active
Free Triiodothyronine (FT3) Calibrator	DR-CAL-CK-A025	EUDAMED	IVD General	Active
Anti-thyroid Peroxidase Antibody Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A035	EUDAMED	IVD General	Active
Carcinoembryonic Antigen (CEA)/Alpha-Fetoprotein (AFP) Diagnostic Kit (TRFIA)	DR-CM-A019	EUDAMED	IVD General	Active
Soluble Fms-like Tyrosine Kinase-1 Diagnostic Kit (CLIA)	DR-CLIA-CK-A029	EUDAMED	IVD General	Active
Cardiac Fatty Acid Binding Protein Calibrator	DR-CAL-CK-A027	EUDAMED	IVD General	Active
Estradiol Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-B007	EUDAMED	IVD General	Active
Neuron-specific Enolase Calibrator	DR-CAL-CM-A005	EUDAMED	IVD General	Active
Myoglobin Calibrator	DR-CAL-CK-A031	EUDAMED	IVD General	Active
Alpha-fetoprotein and Human Chorionic Gonadotropin Free β Subunit Quantitative Diagnostic Kit (TRFIA)	DR-PS-A002	EUDAMED	IVD General	Active
Neutrophil Gelatinase-Associated Lipocalinn Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A046	EUDAMED	IVD General	Active
Pregnancy Associated Plasma Protein A Diagnostic Kit (CLIA)	DR-CLIA-CK-A026	EUDAMED	IVD General	Active
Clonorchis Sinensis Antibody Diagnostic Kit (ELISA)	DR-PA-A001	EUDAMED	IVD General	Active
Free β Human Chorionic Gonadotrophin Diagnostic Kit (CLIA)	DR-CLIA-CK-A027	EUDAMED	IVD General	Active
Alpha-Fetoprotein Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CM-B001	EUDAMED	IVD General	Active
Luteinizing Hormone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-B001	EUDAMED	IVD General	Active
Total β Human Chorionic Gonadotrophin Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-B004	EUDAMED	IVD General	Active

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