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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 6 of 9

Device	Model / Reference	Registries	Class	Status
CA125 CLIA Microparticles	CMB0602	EUDAMED	Class C	Active
Anti-TPO CLIA Microparticles	CME0705	EUDAMED	Class B	Active
PIVKA-Ⅱ CLIA Microparticles	CMB2003	EUDAMED	Class C	Active
AutoLumo Anti-CL IgG Calibrators	CA013203	EUDAMED	Class C	Active
Anti-PR3 IgG CLIA Microparticles	CMQ1503	EUDAMED	Class B	Active
PCT CLIA Microparticles	CMR0205	EUDAMED	Class C	Active
Thyroid Speciality Control	ZK0501L306	EUDAMED	Class B	Active
DHEA-S CLIA Microparticles	CMF0705	EUDAMED	Class B	Active
rT3 CLIA Microparticles	CME1103	EUDAMED	Class B	Active
Gram Negative bacteria ID	ME0602	EUDAMED	Class C	Active
f23 CLIA Microparticles	CMQA1202	EUDAMED	Class B	Active
CMV IgG CLIA Microparticles	CMK0703	EUDAMED	Class C	Active
hs-CRP CLIA Microparticles	CMR0105	EUDAMED	Class C	Active
Anti-CL IgG CLIA Microparticles	CMQ3505	EUDAMED	Class C	Active
PepsinogenⅡ CLIA Microparticles	CMB1605	EUDAMED	Class C	Active
Insulin CLIA Microparticles	CMG0101	EUDAMED	Class C	Active
Pepsinogen Ⅱ CLIA Microparticles	CMB1610	EUDAMED	Class C	Active
NSE CLIA Microparticles	CMB1103	EUDAMED	Class C	Active
Anti-Sm IgG CLIA Microparticles	CMQ2005	EUDAMED	Class B	Active
Anti-gp210 IgG CLIA Microparticles	CMQ2510	EUDAMED	Class B	Active
ANA IgG CLIA Microparticles	CMQ3305	EUDAMED	Class B	Active
Wash Buffer	CMO0306	EUDAMED	Class A	Active
f1 CLIA Microparticles	CMQA0502	EUDAMED	Class B	Active
fPSA CLIA Microparticles	CMB0505	EUDAMED	Class C	Active
PINP CLIA Microparticles	CMS0710	EUDAMED	Class B	Active
Autoimmune Maker Control I	ZKE010201	EUDAMED	Class B	Active
Anaerobic Culture Bottle FN	MC0302	EUDAMED	Class A	Active
Inflammation Markers Control	ZK0401L201	EUDAMED	Class C	Active
Anti-GBM IgG CLIA Microparticles	CMQ1705	EUDAMED	Class B	Active
PRG CLIA Microparticles	CMF0605	EUDAMED	Class B	Active
Mycobacterial Culture Bottle	MC0401	EUDAMED	Class C	Active
H-FABP CLIA Microparticles	CMH1110	EUDAMED	Class C	Active
Aerobic Culture Bottle SP	MC0305	EUDAMED	Class A	Active
AutoLumo AMH Calibrators	CA050301	EUDAMED	Class B	Active
AutoLumo PINP Calibrators	CA220101	EUDAMED	Class B	Active
Anti-gp210 IgG CLIA Microparticles	CMQ2503	EUDAMED	Class B	Active
Yeast Id/Ast	ME0303	EUDAMED	Class C	Active
AutoLumo 25-OH Vitamin D Calibrators	CA110301	EUDAMED	Class B	Active
tIgE CLIA Microparticles	CMQ0602	EUDAMED	Class B	Active
Anti-CL CLIA Microparticles	CMQ3408	EUDAMED	Class C	Active
fPSA CLIA Microparticles	CMB0502	EUDAMED	Class C	Active
AMH Control	ZK0101L202	EUDAMED	Class B	Active
DHEA-S CLIA Microparticles	CMF0702	EUDAMED	Class B	Active
FT3 CLIA Microparticles	CME0405	EUDAMED	Class B	Active
Ast-Gp01	ME1102	EUDAMED	Class C	Active
CEA CLIA Microparticles	CMB0201	EUDAMED	Class C	Active
e5 CLIA Microparticles	CMQA0402	EUDAMED	Class B	Active
Ferritin CLIA Microparticles	CMB0905	EUDAMED	Class C	Active
Lytic Anaerobic Culture Bottle	MC0503	EUDAMED	Class A	Active
AutoLumo ANA IgG Calibrators	CA013003	EUDAMED	Class B	Active

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