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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 3 of 9

Device	Model / Reference	Registries	Class	Status
AutoLumo Anti-Scl-70 IgG Calibrators	CA011203	EUDAMED	Class B	Active
Mycoplasma (UU-MH) Culture Broth	M0204	EUDAMED	Class C	Active
LH CLIA Microparticles	CMF0105	EUDAMED	Class B	Active
ToRCH IgM Control	ZKB0302	EUDAMED	Class C	Active
Toxo IgG CLIA Microparticles	CMK0605	EUDAMED	Class C	Active
AutoLumo Anti-dsDNA IgG Calibrators	CA012903	EUDAMED	Class B	Active
BNP CLIA Microparticles	CMH0803	EUDAMED	Class C	Active
Fungus AST	MD0403	EUDAMED	Class C	Active
CMV IgM CLIA Microparticles	CMK0202	EUDAMED	Class C	Active
IL-6 CLIA Microparticles	CMH0505	EUDAMED	Class C	Active
Anti-Sm IgG CLIA Microparticles	CMQ2010	EUDAMED	Class B	Active
G-17 CLIA Microparticles	CMB2103	EUDAMED	Class B	Active
PTH CLIA Microparticles	CME0901	EUDAMED	Class B	Active
f10 CLIA Microparticles	CMQA0902	EUDAMED	Class B	Active
AutoLumo CA15-3 Calibrators	CA060104	EUDAMED	Class C	Active
AMH CLIA Microparticles	CMS0501	EUDAMED	Class B	Active
Anaerobic culture bottle SN	MC0309	EUDAMED	Class A	Active
Anti-β2-GP1 IgM CLIA Microparticles	CMQ3203	EUDAMED	Class C	Active
f4 CLIA Microparticles	CMQA0802	EUDAMED	Class B	Active
PCT CLIA Microparticles	CMR0201	EUDAMED	Class C	Active
AutoLumo CA19-9 Calibrators	CA060402	EUDAMED	Class C	Active
AutoLumo Anti-sp100 IgG Calibrators	CA012203	EUDAMED	Class B	Active
AutoLumo Anti-nRNP/Sm IgG Calibrators	CA011503	EUDAMED	Class B	Active
Folate CLIA Micropartilces	CMS0205	EUDAMED	Class B	Active
NT-proBNP CLIA Microparticles	CMH0405	EUDAMED	Class C	Active
Anti-CL IgG CLIA Microparticles	CMQ3508	EUDAMED	Class C	Active
MYO CLIA Microparticles	CMH0102	EUDAMED	Class C	Active
ToRCH IgM Control	ZKB0102	EUDAMED	Class C	Active
AutoLumo Anti-gp210 IgG Calibrators	CA012203	EUDAMED	Class B	Active
Ast-Nf01	ME1002	EUDAMED	Class C	Active
RF IgA CLIA Microparticles	CMQ1305	EUDAMED	Class B	Active
Ast-Eb01	ME0903	EUDAMED	Class C	Active
25-OH Vitamin D CLIA Microparticles	CMS0403	EUDAMED	Class B	Active
CA72-4 CLIA Microparticles	CMB1402	EUDAMED	Class C	Active
f14 CLIA Microparticles	CMQA1102	EUDAMED	Class B	Active
AutoLumo SCCA Calibrators	CA060801	EUDAMED	Class C	Active
Gram Positive bacteria ID	ME0505	EUDAMED	Class C	Active
IGF-1 CLIA Microparticles	CML0105	EUDAMED	Class B	Active
Streptococcus AST	MD0201	EUDAMED	Class C	Active
FSH CLIA Microparticles	CMF0205	EUDAMED	Class B	Active
AutoLumo Anti-TPO Calibrators	CA120101	EUDAMED	Class B	Active
Anti-MPO IgG CLIA Microparticles	CMQ1610	EUDAMED	Class B	Active
Non-fermenting bacteria AST	MD0103	EUDAMED	Class C	Active
Anti-CL CLIA Microparticles	CMQ3403	EUDAMED	Class C	Active
AutoLumo Anti-β2-GP1 IgA Calibrators	CA012603	EUDAMED	Class C	Active
AutoLumo ProGRP Calibrators	CA062101	EUDAMED	Class C	Active
HER-2/neu CLIA Microparticles	CMB2210	EUDAMED	Class C	Active
AutoLumo CK-MB Calibrators	CA140201	EUDAMED	Class C	Active
HS-cTnT CLIA Microparticles	CMH0610	EUDAMED	Class C	Active
RF CLIA Microparticles	CMQ1001	EUDAMED	Class B	Active

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