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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 4 of 9

Device	Model / Reference	Registries	Class	Status
BNP CLIA Microparticles	CMH0805	EUDAMED	Class C	Active
Anti-gp210 IgG CLIA Microparticles	CMQ2508	EUDAMED	Class B	Active
SCCA CLIA Microparticles	CMB1307	EUDAMED	Class C	Active
AutoLumo PRG Calibrators	CA080201	EUDAMED	Class B	Active
Renin CLIA Microparticles	CMD0402	EUDAMED	Class B	Active
H-FABP CLIA Microparticles	CMH1105	EUDAMED	Class C	Active
AutoLumo Anti-Sm IgG Calibrators	CA011403	EUDAMED	Class B	Active
f13 CLIA Microparticles	CMQA1002	EUDAMED	Class B	Active
AutoLumo PIVKA-II CLIA Calibrators	CA061001	EUDAMED	Class C	Active
Aerobic culture bottle SA	MC0307	EUDAMED	Class A	Active
B19 IgG CLIA Microparticles	CMK1103	EUDAMED	Class C	Active
Rubella IgG CLIA Microparticles	CMK0805	EUDAMED	Class C	Active
HGH CLIA Microparticles	CML0202	EUDAMED	Class B	Active
Endocrine Control II	ZKE0201	EUDAMED	Class C	Active
AutoLumo G-17 Calibrators	CA061901	EUDAMED	Class B	Active
cTnI CLIA Microparticles	CMH0203	EUDAMED	Class C	Active
Tumour Marker Control II	ZKM0201	EUDAMED	Class C	Active
AutoLumo Pepsinogen Ⅱ Calibrators	CA061601	EUDAMED	Class C	Active
TSH CLIA Microparticles	CME0303	EUDAMED	Class B	Active
PepsinogenⅡ CLIA Microparticles	CMB1603	EUDAMED	Class C	Active
AutoLumo FSH Calibrators	CA080501	EUDAMED	Class B	Active
cTnI CLIA Microparticles	CMH0205	EUDAMED	Class C	Active
HSV-1 IgM CLIA Microparticles	CMK0403	EUDAMED	Class C	Active
Anti-β2-GP1 IgA CLIA Microparticles	CMQ3005	EUDAMED	Class C	Active
AutoLumo Pepsinogen Ⅰ Calibrators	CA061501	EUDAMED	Class C	Active
w1 CLIA Microparticles	CMQA2202	EUDAMED	Class B	Active
Anti-CCP IgG CLIA Microparticles	CMQ1410	EUDAMED	Class B	Active
IGFBP-3 CLIA Microparticles	CML0305	EUDAMED	Class B	Active
NSE CLIA Microparticles	CMB1105	EUDAMED	Class C	Active
Mycoplasma TIES	M0206	EUDAMED	Class C	Active
Anti-Scl-70 IgG CLIA Microparticles	CMQ1805	EUDAMED	Class B	Active
Lytic Anaerobic Culture Bottle	MC0501	EUDAMED	Class A	Active
Mycobacterial Culture Bottle	MC0403	EUDAMED	Class C	Active
AutoLumo S100 Calibrators	CA062301	EUDAMED	Class C	Active
Gram Positive bacteria ID/AST	ME0102	EUDAMED	Class C	Active
AFP CLIA Microparticles	CMB0101	EUDAMED	Class C	Active
Gram Positive bacteria AST	MD0303	EUDAMED	Class C	Active
AutoLumo CA72-4 Calibrators	CA060204	EUDAMED	Class C	Active
tPSA CLIA Microparticles	CMB0305	EUDAMED	Class C	Active
Chemiluminescent Substrate	CMO0101	EUDAMED	Class A	Active
Anti-TG CLIA Microparticles	CME0610	EUDAMED	Class B	Active
Aerobic Culture Bottle FA	MC0301	EUDAMED	Class A	Active
β2-Microglobulin CLIA Microparticles	CMB1001	EUDAMED	Class B	Active
Anti-β2-GP1 IgG CLIA Microparticles	CMQ3108	EUDAMED	Class C	Active
t3 CLIA Microparticles	CMQA2002	EUDAMED	Class B	Active
Osteocalcin CLIA Microparticles	CMS0103	EUDAMED	Class B	Active
d1 CLIA Microparticles	CMQA0102	EUDAMED	Class B	Active
CA15-3 CLIA Microparticles	CMB0705	EUDAMED	Class C	Active
AutoLumo Anti-CL IgM Calibrators	CA013303	EUDAMED	Class C	Active
Anti-sp100 IgG CLIA Microparticles	CMQ2603	EUDAMED	Class B	Active

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