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Autobio Diagnostics Co., Ltd.

China·CN-MF-000003348

Last updated September 17, 2026

Information

Country: China
Address: No. 87 , Jingbei Yi Road, Zhengzhou, China
Website: autobio-diagnostics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Bin Li
EUDAMED SRN: CN-MF-000003348
FDA FEI Number: 3006537286
DUNS Number: —

Catalogue (413)

Page 5 of 9

Device	Model / Reference	Registries	Class	Status
f2 CLIA Microparticles	CMQA0602	EUDAMED	Class B	Active
ANA IgG CLIA Microparticles	CMQ3310	EUDAMED	Class B	Active
T4 CLIA Microparticles	CME0203	EUDAMED	Class B	Active
HSV-2 IgG CLIA Microparticles	CMK1002	EUDAMED	Class C	Active
Gram Positive bacteria ID	ME0506	EUDAMED	Class C	Active
AutoLumo LH Calibrators	CA080401	EUDAMED	Class B	Active
Anti-MPO IgG CLIA Microparticles	CMQ1608	EUDAMED	Class B	Active
Anti-β2-GP1 IgG CLIA Microparticles	CMQ3105	EUDAMED	Class C	Active
Saline Solution	ME1606	EUDAMED	Class A	Active
Anti-CL CLIA Microparticles	CMQ3405	EUDAMED	Class C	Active
Cardiac Markers Control	ZKD0307	EUDAMED	Class C	Active
Preservation	CMO0902	EUDAMED	Class A	Active
AutoLumo CA242 Calibrators	CA060302	EUDAMED	Class C	Active
rT3 CLIA Microparticles	CME1105	EUDAMED	Class B	Active
CA15-3 CLIA Microparticles	CMB0703	EUDAMED	Class C	Active
Yeast Id/Ast	ME0301	EUDAMED	Class C	Active
e1 CLIA Microparticles	CMQA0302	EUDAMED	Class B	Active
S100 CLIA Microparticles	CMB2310	EUDAMED	Class C	Active
AutoLumo E2 Calibrators	CA080101	EUDAMED	Class B	Active
Fungus AST	MD0402	EUDAMED	Class C	Active
Mycoplasma IES Plus	MA06	EUDAMED	Class C	Active
PIVKA-II CLIA Microparticles	CMB2002	EUDAMED	Class C	Active
AutoLumo CYFRA 21-1 Calibrators	CA061801	EUDAMED	Class C	Active
Enterobacteriaceae AST	MD0501	EUDAMED	Class C	Active
AutoLumo Anti-β2-GP1 IgM Calibrators	CA012803	EUDAMED	Class C	Active
Aerobic Culture Bottle PF	MC0303	EUDAMED	Class A	Active
ToRCH IgG Control	ZKA0102	EUDAMED	Class C	Active
Anti-PR3 IgG CLIA Microparticles	CMQ1505	EUDAMED	Class B	Active
Ast-Eb01	ME0902	EUDAMED	Class C	Active
CK-MB CLIA Microparticles	CMH0305	EUDAMED	Class C	Active
T4 CLIA Microparticles	CME0201	EUDAMED	Class B	Active
AutoLumo Anti-CL Calibrators	CA013103	EUDAMED	Class C	Active
Anti-β2-GP1 CLIA Microparticles	CMQ2905	EUDAMED	Class C	Active
Folate CLIA Microparticles	CMS0202	EUDAMED	Class B	Active
Anti-CL IgA CLIA Microparticles	CMQ3708	EUDAMED	Class C	Active
HSV-2 IgM CLIA Microparticles	CMK0505	EUDAMED	Class C	Active
Folate CLIA Micropartilces	CMS0203	EUDAMED	Class B	Active
β2-Microglobulin CLIA Microparticles	CMB1003	EUDAMED	Class B	Active
B19 IgG CLIA Microparticles	CMK1105	EUDAMED	Class C	Active
TG CLIA Microparticles	CME0805	EUDAMED	Class C	Active
C-Peptide CLIA Microparticles	CMG0203	EUDAMED	Class C	Active
IL-6 CLIA Microparticles	CMH0503	EUDAMED	Class C	Active
AutoLumo Anti-Ribosomal P IgG Calibrators	CA011603	EUDAMED	Class B	Active
HSV-2 IgM CLIA Microparticles	CMK0503	EUDAMED	Class C	Active
Anti-GBM IgG CLIA Microparticles	CMQ1710	EUDAMED	Class B	Active
Anti-CL IgM CLIA Microparticles	CMQ3603	EUDAMED	Class C	Active
w6 CLIA Microparticles	CMQA2302	EUDAMED	Class B	Active
TRAb CLIA Microparticles	CME1002	EUDAMED	Class B	Active
Anti-nRNP/Sm IgG CLIA Microparticles	CMQ2110	EUDAMED	Class B	Active
Sample Release Reagent	CMT1403	EUDAMED	Class A	Active

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