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DiYaLab ZJG Biotech Co., Ltd

China·CN-MF-000048648

Last updated June 8, 2026

Information

Country: China
Address: Room 211, Building A, Room 203, 206 and 207, Building B No.36, Huada Road, , Zhangjiagang, Jiangsu, China
Website: fermatbiotech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jing Li
EUDAMED SRN: CN-MF-000048648
FDA FEI Number: —
DUNS Number: —

Catalogue (134)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Anti-PR3 Assay Kit(Fluorescence Immunoassay)	DL234606	EUDAMED	IVD General	Active
Anti-aPS/PT IgM CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-β2-Glycoprotein I IgM CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-SSB Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
U1-RNP Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
HbA1c Assay Kit (Fluorescence Immunoassay)	DL233706	EUDAMED	IVD General	Active
KL-6 Assay Kit (Fluorescence Immunoassay)	20 tests/ kit	EUDAMED	IVD General	Active
Anti-β2-Glycoprotein I IgA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Chemiluminescent Substrate	DC200402E	EUDAMED	Class A	Active
Anti-Myeloperoxidase CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Helicobacter pylori Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Free IgE Assay Kit (Fluorescence Immunoassay)	20 tests/ kit	EUDAMED	IVD General	Active
Rheumatoid Factor IgA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Rheumatoid Factor Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
System Wash	DC200303E	EUDAMED	Class A	Active
Fluorescence Immunoassay Analyzer	DL300	EUDAMED	Class A	Active
Anti-Jo-1 Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
ANA Assay Kit (Fluorescence Immunoassay)	DL233907	EUDAMED	IVD General	Active
Anti-PCNA Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Free T4 CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Scl-70 Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-β2-GPI IgG/IgM Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-GBM CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Cardiac Troponin T Assay Kit (Fluorescence Immunoassay)	20 tests/ kit	EUDAMED	IVD General	Active
Anti-His Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-MCV CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Rheumatoid Factor IgG/IgM/IgA Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Interleukin - 6 Assay Kit (Fluorescence Immunoassay)	DL190405	EUDAMED	IVD General	Active
GADA Assay Kit (Fluorescence Immunoassay)	DL246506	EUDAMED	IVD General	Active
Procalcitonin Assay Kit(Fluorescence Immunoassay)	20 tests/ kit	EUDAMED	IVD General	Active
TRAb CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Chemiluminescent Substrate	100mL×1	EUDAMED	Class A	Active
Anti-PM-Scl Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-CCP CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active

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Notified Bodies

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Authorities

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