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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Free Thyroxine (FT4) Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A032	EUDAMED	IVD General	Active
Follicle Stimulating Hormone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-B003	EUDAMED	IVD General	Active
Cytokeratin 19-Fragments Calibrator	DR-CAL-CM-A010	EUDAMED	IVD General	Active
Luteinizing Hormone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-HO-A001	EUDAMED	IVD General	Active
Placental Growth Factor Diagnostic Kit (CLIA)	DR-CLIA-CK-A030	EUDAMED	IVD General	Active
Pepsinogen I/II Diagnostic Kit (TRFIA)	DR-CM-A018	EUDAMED	IVD General	Active
Carcinoembryonic Antigen Calibrator	DR-CAL-CM-A002	EUDAMED	IVD General	Active
Human Ferritin (hFER) Quantitative Diagnostic Kit (TRFIA)	DR-OT-A001	EUDAMED	IVD General	Active
Carcinoembryonic Antigen Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CM-A002	EUDAMED	IVD General	Active
Neuron-specific Enolase Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CM-B005	EUDAMED	IVD General	Active
C-peptide Quantitative Diagnostic Kit (TRFIA)	DR-IC-A002	EUDAMED	IVD General	Active
Cardiac Troponin T Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A042	EUDAMED	IVD General	Active
Quantitative Diagnostic Kit for Neonatal Thyroid Stimulating Hormone (TRFIA)	DR-NS-A001	EUDAMED	IVD General	Active
D-Dimer Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A039	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A037	EUDAMED	IVD General	Active
Free Estriol Calibrator	DR-CAL-CK-A012	EUDAMED	IVD General	Active
Cancer Antigen 125 (CA125) Diagnostic Kit (TRFIA)	DR-CM-A014	EUDAMED	IVD General	Active
Carbohydrate Antigen 15-3 Calibrator	DR-CAL-CM-A006	EUDAMED	IVD General	Active
Total Triiodothyronine (TT3) Quantitative Diagnostic Kit (TRFIA)	DR-TR-A001	EUDAMED	IVD General	Active
Cancer Antigen 125 Diagnostic Kit (CLIA)	DR-CLIA-CM-A007	EUDAMED	IVD General	Active
Human Growth Hormone Quantitative Diagnostic Kit (TRFIA)	DR-HO-A006	EUDAMED	IVD General	Active
Human Chorionic Gonadotropin (hCG) Quantitative Diagnostic Kit (TRFIA)	DR-HO-A001	EUDAMED	IVD General	Active
Alpha-Fetoprotein Calibrator	DR-CAL-CM-A001	EUDAMED	IVD General	Active
Free Thyroxine (FT4) Calibrator	DR-CAL-CK-A019	EUDAMED	IVD General	Active
2019 Novel Coronavirus (2019-nCoV) Antigen Qualitative Diagnostic Kit (CLIA)	DR-CLIA-nCoV-A002	EUDAMED	IVD General	Active
Creatine Kinase Isoenzyme (CK-MB) Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A045	EUDAMED	IVD General	Active
Diagnostic Kit for the Quantitative Detection of Alpha-fetoprotein (TRFIA )	DR-PS-A001	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CM-B009	EUDAMED	IVD General	Active
Cytokeratin 19-fragments Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CM-B010	EUDAMED	IVD General	Active
Cancer Antigen 125 Diagnostic Kit (CLIA)	DR-CLIA-CM-B007	EUDAMED	IVD General	Active
Free Thyroxin (FT4) Quantitative Diagnostic Kit (TRFIA)	DR-TR-A004	EUDAMED	IVD General	Active
Creatine Kinase Isoenzyme (CK-MB) Calibrator	DR-CAL-CK-A032	EUDAMED	IVD General	Active
Cancer Antigen 125 Calibrator	DR-CAL-CM-A007	EUDAMED	IVD General	Active
Anti-thyroglobulin Antibody Calibrator	DR-CAL-CK-A020	EUDAMED	IVD General	Active
Neutrophil Gelatinase-Associated Lipocalinn Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-B046	EUDAMED	IVD General	Active
Carbohydrate Antigen 50 Calibrator	DR-CAL-CM-A008	EUDAMED	IVD General	Active
Human Pregnancy-associated Plasma Protein A Quantitative Diagnostic Kit (TRFIA)	DR-HO-A011	EUDAMED	IVD General	Active
Thyroglobulin Calibrator	DR-CAL-CK-A021	EUDAMED	IVD General	Active
Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit (TRFIA)	DR-CM-A015	EUDAMED	IVD General	Active
Human-Insulin (hInsulin) Quantitative Diagnostic Kit (TRFIA)	DR-IC-A001	EUDAMED	IVD General	Active
Cardiac Troponin T Calibrator	DR-CAL-CK-A029	EUDAMED	IVD General	Active
Carbohydrate Antigen 15-3 Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CM-B006	EUDAMED	IVD General	Active
Human Thyroid Stimulating Hormone Quantitative Diagnostic Kit (TRFIA)	DR-TR-A005	EUDAMED	IVD General	Active
Free Triiodothyronine (FT3) Quantitative Diagnostic Kit (TRFIA)	DR-TR-A002	EUDAMED	IVD General	Active
Carbohydrate Antigen 50 Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CM-A008	EUDAMED	IVD General	Active
Anti-thyroid Peroxidase Antibody Calibrator	DR-CAL-CK-A022	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Calibrator	DR-CAL-CK-A024	EUDAMED	IVD General	Active
Total Triiodothyronine (TT3) Quantitative Diagnostic Kit (CLIA)	DR-CLIA-CK-A036	EUDAMED	IVD General	Active
Treponema Pallidum (TP) Antibody Diagnostic Kit (TRFIA)	DR-ID-A007	EUDAMED	IVD General	Active
Total Thyroxine (TT4) Quantitative Diagnostic Kit (TRFIA)	DR-TR-A003	EUDAMED	IVD General	Active

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