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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 1 of 9

Device	Model / Reference	Registries	Class	Status
CA125 CLIA Microparticles	CMB0606	EUDAMED	Class C	Active
AutoLumo Anti-MPO IgG Calibrators	CA011803	EUDAMED	Class B	Active
AutoLumo RF IgG Calibrators	CA010603	EUDAMED	Class B	Active
AutoLumo Anti-Jo-1 IgG Calibrators	CA011303	EUDAMED	Class B	Active
Anti-CL CLIA Microparticles	CMQ3410	EUDAMED	Class C	Active
AutoLumo TG Calibrators	CA120301	EUDAMED	Class C	Active
AutoLumo T4 Calibrators	CA120801	EUDAMED	Class B	Active
B19 IgM CLIA Microparticles	CMK1205	EUDAMED	Class C	Active
RF IgG CLIA Microparticles	CMQ1210	EUDAMED	Class B	Active
AutoLumo HE4 Calibrators	CA062001	EUDAMED	Class C	Active
PCT CLIA Microparticles	CMR0203	EUDAMED	Class C	Active
AutoLumo PIVKA-II CLIA Calibrators	CA061002	EUDAMED	Class C	Active
AutoLumo CA50 Calibrators	CA061701	EUDAMED	Class C	Active
B19 IgM CLIA Microparticles	CMK1203	EUDAMED	Class C	Active
HER-2/neu CLIA Microparticles	CMB2203	EUDAMED	Class C	Active
HSV-2 IgM CLIA Microparticles	CMK0502	EUDAMED	Class C	Active
AutoLumo RF Calibrators	CA010403	EUDAMED	Class B	Active
Cardiac Markers Control	ZKD0107	EUDAMED	Class C	Active
Filamentous Fungi Pretreatment Reagent	MSA05	EUDAMED	Class A	Active
NT-proBNP CLIA Microparticles	CMH0410	EUDAMED	Class C	Active
Preservation	CMO0905	EUDAMED	Class A	Active
HE4 CLIA Microparticles	CMB1803	EUDAMED	Class C	Active
Anti-Scl-70 IgG CLIA Microparticles	CMQ1810	EUDAMED	Class B	Active
Filamentous Fungi Diluent	ME1706	EUDAMED	Class A	Active
Wash Buffer	CMO0301	EUDAMED	Class A	Active
HSV-1 IgG CLIA Microparticles	CMK0902	EUDAMED	Class C	Active
IGFBP-3 CLIA Microparticles	CML0303	EUDAMED	Class B	Active
PepsinogenⅠ CLIA Microparticles	CMB1505	EUDAMED	Class C	Active
Tumour Marker Control II	ZKM0301	EUDAMED	Class C	Active
AutoLumo Insulin Calibrators	CA090101	EUDAMED	Class C	Active
25-OH Vitamin D CLIA Microparticles	CMS0401	EUDAMED	Class B	Active
Filamentous Fungi Diluent	ME1708	EUDAMED	Class A	Active
HE4 CLIA Microparticles	CMB1810	EUDAMED	Class C	Active
m6 CLIA Microparticles	CMQA1902	EUDAMED	Class B	Active
Gram Negative bacteria ID	ME0604	EUDAMED	Class C	Active
AutoLumo B19 IgM Calibrators	CA170201	EUDAMED	Class C	Active
ANA IgG CLIA Microparticles	CMQ3301	EUDAMED	Class B	Active
CA125 CLIA Microparticles	CMB0603	EUDAMED	Class C	Active
17α-OHP CLIA Microparticles	CMF0902	EUDAMED	Class B	Active
Gram Positive bacteria ID/AST	ME0101	EUDAMED	Class C	Active
h1 CLIA Microparticles	CMQA1602	EUDAMED	Class B	Active
Vitamin B12 CLIA Microparticles	CMS0303	EUDAMED	Class B	Active
AutoLumo HS-cTnT Calibrators	CA100701	EUDAMED	Class C	Active
CHCA Matrix for use with AUTOF MS	MSA03	EUDAMED	Class A	Active
Vitamin B12 CLIA Microparticles	CMS0302	EUDAMED	Class B	Active
AutoLumo SCCA Calibrators	CA060802	EUDAMED	Class C	Active
β2-Microglobulin CLIA Microparticles	CMB1002	EUDAMED	Class B	Active
HSV-1 IgG CLIA Microparticles	CMK0903	EUDAMED	Class C	Active
i6 CLIA Microparticles	CMQA1702	EUDAMED	Class B	Active
Anti-Jo-1 IgG CLIA Microparticles	CMQ1908	EUDAMED	Class B	Active

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