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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 2 of 9

Device	Model / Reference	Registries	Class	Status
AutoLumo tIgE Calibrators	CA010103	EUDAMED	Class B	Active
PepsinogenⅠ CLIA Microparticles	CMB1503	EUDAMED	Class C	Active
Anti-gp210 IgG CLIA Microparticles	CMQ2505	EUDAMED	Class B	Active
SCCA CLIA Microparticles	CMB1302	EUDAMED	Class C	Active
Anti-sp100 IgG CLIA Microparticles	CMQ2608	EUDAMED	Class B	Active
SCCA CLIA Microparticles	CMB1305	EUDAMED	Class C	Active
Anti-dsDNA IgG CLIA Microparticles	CMQ2305	EUDAMED	Class B	Active
HE4 CLIA Microparticles	CMB1805	EUDAMED	Class C	Active
HSV-1 IgM CLIA Microparticles	CMK0405	EUDAMED	Class C	Active
HER-2/neu CLIA Microparticles	CMB2205	EUDAMED	Class C	Active
PTH CLIA Microparticles	CME0905	EUDAMED	Class B	Active
Anti-β2-GP1 CLIA Microparticles	CMQ2910	EUDAMED	Class C	Active
AutoLumo RF IgM Calibrators	CA010503	EUDAMED	Class B	Active
T4 CLIA Microparticles	CME0202	EUDAMED	Class B	Active
CYFRA 21-1 CLIA Microparticles	CMB1210	EUDAMED	Class C	Active
DHEA-S CLIA Microparticles	CMF0703	EUDAMED	Class B	Active
AMH Control	ZK0101L302	EUDAMED	Class B	Active
BNP CLIA Microparticles	CMH0802	EUDAMED	Class C	Active
System Wash	CMO0401	EUDAMED	Class A	Active
Autoimmune Maker Control I	ZKE010101	EUDAMED	Class B	Active
d2 CLIA Microparticles	CMQA0202	EUDAMED	Class B	Active
AutoLumo B19 IgG Calibrators	CA170101	EUDAMED	Class C	Active
AutoLumo NT-proBNP Calibrators	CA140101	EUDAMED	Class C	Active
Preservation	CMO0901	EUDAMED	Class A	Active
AutoLumo PTH Calibrators	CA120201	EUDAMED	Class B	Active
Gram Negative bacteria ID	ME0606	EUDAMED	Class C	Active
Anaerobic culture bottle SN	MC0306	EUDAMED	Class A	Active
t12 CLIA Microparticles	CMQA2102	EUDAMED	Class B	Active
Anti-Ribosomal P IgG CLIA Microparticles	CMQ2210	EUDAMED	Class B	Active
AutoLumo Anti-TG Calibrators	CA120501	EUDAMED	Class B	Active
Gram Negative bacteria ID/AST	ME0203	EUDAMED	Class C	Active
Toxo IgM CLIA Microparticles	CMK0102	EUDAMED	Class C	Active
AutoLumo IL-6 Calibrators	CA100401	EUDAMED	Class C	Active
S100 CLIA Microparticles	CMB2303	EUDAMED	Class C	Active
AutoLumo C-Peptide Calibrators	CA090201	EUDAMED	Class C	Active
Sputum Processing Reagent	AS030101	EUDAMED	Class A	Active
Positive Blood Cultures Pretreatment Reagent	MSA04	EUDAMED	Class A	Active
AutoLumo Osteocalcin Calibrators	CA110101	EUDAMED	Class B	Active
SHBG CLIA Microparticles	CMF0802	EUDAMED	Class B	Active
Anti-nRNP/Sm IgG CLIA Microparticles	CMQ2105	EUDAMED	Class B	Active
W0102060309	CMS0405	EUDAMED	Class B	Active
Gram Negative bacteria ID	ME0601	EUDAMED	Class C	Active
Rubella IgG CLIA Microparticles	CMK0801	EUDAMED	Class C	Active
Mycoplasma IES	M0205	EUDAMED	Class C	Active
Pepsinogen Ⅰ CLIA Microparticles	CMB1510	EUDAMED	Class C	Active
SCCA CLIA Microparticles	CMB1303	EUDAMED	Class C	Active
CA50 CLIA Microparticles	CMB0405	EUDAMED	Class C	Active
AutoLumo AMA-M2 IgG Calibrators	CA012003	EUDAMED	Class B	Active
AutoLumo Anti-CCP IgG Calibrators	CA010203	EUDAMED	Class B	Active
AutoLumo Anti-β2-GP1 Calibrators	CA012503	EUDAMED	Class C	Active

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