Is this your brand? Sign in to claim ownership.

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 (150)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Anti-tTg IgA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Jo-1 Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Calprotectin Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)	DL234406	EUDAMED	IVD General	Active
Anti-Sm Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
MDA5 Assay Kit (Fluorescence Immunoassay)	20 tests/ kit	EUDAMED	IVD General	Active
Free IgE Assay Kit (Fluorescence Immunoassay)	DL245506	EUDAMED	IVD General	Active
Anti-SSA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-tTg IgG CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-SSB CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-β2-GPI Domain 1 IgG Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
N-terminal pro-brain nitric peptide Assay Kit (Fluorescence Immunoassay)	DL190805	EUDAMED	IVD General	Active
U1-RNP Assay Kit (Fluorescence Immunoassay)	DL234106	EUDAMED	IVD General	Active
Anti-Cardiolipin IgA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-cyclic citrullinic peptide antibody Assay Kit(Fluorescence Immunoassay)	DL191405	EUDAMED	IVD General	Active
TPOAb CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
ANA Screening Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-SSA Assay Kit (Fluorescence Immunoassay)	DL244702	EUDAMED	IVD General	Active
Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay)	DL191206	EUDAMED	IVD General	Active
Cardiac Troponin I Assay Kit (Fluorescence Immunoassay)	DL191005	EUDAMED	IVD General	Active
Anti-streptolysin O Assay Kit（Fluorescence Immunoassay）	DL239406	EUDAMED	IVD General	Active
GADA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Rheumatoid Factor CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Ferritin Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-dsDNA Assay Kit (Fluorescence Immunoassay)	DL239206	EUDAMED	IVD General	Active
Cardiac Troponin T Assay Kit (Fluorescence Immunoassay)	DL191105	EUDAMED	IVD General	Active
Anti-dsDNA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-MPO Assay Kit (Fluorescence Immunoassay)	DL234506	EUDAMED	IVD General	Active
Cystatin C Assay Kit (Fluorescence Immunoassay)	DL246002	EUDAMED	IVD General	Active
C- reactive protein Assay Kit(Fluorescence Immunoassay)	DL190107	EUDAMED	IVD General	Active
Anti-MPO Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
D-Dimer Assay Kit（Fluorescence Immunoassay）	20 tests/ kit	EUDAMED	IVD General	Active
T4 CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-MCV Assay Kit (Fluorescence Immunoassay)	20 tests/ kit	EUDAMED	IVD General	Active
TSH CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
KL-6 Assay Kit (Fluorescence Immunoassay)	DL223506	EUDAMED	IVD General	Active
HbA1c Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-Sm/nRNP Antibody CLIA Assay Kit	100 tests/kit.	EUDAMED	IVD General	Active
25-OH VD Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-Ro52 Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-rRNP0 Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Mitochondria M2 CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-CENP Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
25-OH VD Assay Kit（Fluorescence Immunoassay）	DL232506	EUDAMED	IVD General	Active
Anti-centromere Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-PLA2R CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Rheumatoid Factor IgG CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Sm Antibody IgG CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
GADA Assay Kit (Fluorescence Immunoassay)	20 tests/ kit	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

SUNGO Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.