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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 7 of 9

Device	Model / Reference	Registries	Class	Status
Anti-β2-GP1 IgA CLIA Microparticles	CMQ3008	EUDAMED	Class C	Active
AutoLumo Anti-Ro-52 IgG Calibrators	CA010903	EUDAMED	Class B	Active
AutoLumo β-CTX Calibrators	CA220201	EUDAMED	Class B	Active
β-CTX CLIA Microparticles	CMS0810	EUDAMED	Class B	Active
AutoLumo Anti-GBM IgG Calibrators	CA011903	EUDAMED	Class B	Active
HSV-1 IgG CLIA Microparticles	CMK0905	EUDAMED	Class C	Active
RF IgA CLIA Microparticles	CMQ1303	EUDAMED	Class B	Active
AutoLumo PRL Calibrators	CA080601	EUDAMED	Class B	Active
Testosterone CLIA Microparticles	CMF0405	EUDAMED	Class B	Active
Toxo IgM CLIA Microparticles	CMK0103	EUDAMED	Class C	Active
FT4 CLIA Microparticles	CME0503	EUDAMED	Class B	Active
Anti-nRNP/Sm IgG CLIA Microparticles	CMQ2108	EUDAMED	Class B	Active
Chemiluminescent Substrate	CMO0102	EUDAMED	Class A	Active
TG CLIA Microparticles	CME0803	EUDAMED	Class C	Active
Anti-TG CLIA Microparticles	CME0605	EUDAMED	Class B	Active
CA125 CLIA Microparticles	CMB0603	EUDAMED	Class C	Active
hs-CRP CLIA Microparticles	CMR0103	EUDAMED	Class C	Active
Gram Positive bacteria ID	ME0501	EUDAMED	Class C	Active
AutoLumo Calcitonin Calibrators	CA110201	EUDAMED	Class C	Active
Anti-dsDNA IgG CLIA Microparticles	CMQ2310	EUDAMED	Class B	Active
NSE CLIA Microparticles	CMB1102	EUDAMED	Class C	Active
Anti-β2-GP1 IgM CLIA Microparticles	CMQ3208	EUDAMED	Class C	Active
CA19-9 CLIA Microparticles	CMB0803	EUDAMED	Class C	Active
Anti-SS-B IgG CLIA Microparticles	CMQ0908	EUDAMED	Class B	Active
RF IgG CLIA Microparticles	CMQ1203	EUDAMED	Class B	Active
AutoLumo Anti-SS-B IgG Calibrators	CA011003	EUDAMED	Class B	Active
m3 CLIA Microparticles	CMQA1802	EUDAMED	Class B	Active
AMH Control	ZK0101L101	EUDAMED	Class B	Active
CA242 CLIA Microparticles	CMB1705	EUDAMED	Class C	Active
AutoLumo RF IgA Calibrators	CA010703	EUDAMED	Class B	Active
HSV-1 IgM CLIA Microparticles	CMK0402	EUDAMED	Class C	Active
Ast-St01	ME1201	EUDAMED	Class C	Active
Rubella IgM CLIA Microparticles	CMK0305	EUDAMED	Class C	Active
Ast-Nf01	ME1001	EUDAMED	Class C	Active
AutoLumo PCT Calibrators	CA100601	EUDAMED	Class C	Active
H-FABP CLIA Microparticles	CMH1103	EUDAMED	Class C	Active
Streptococcus AST	MD0202	EUDAMED	Class C	Active
Anti-GBM IgG CLIA Microparticles	CMQ1703	EUDAMED	Class B	Active
CMV IgG CLIA Microparticles	CMK0702	EUDAMED	Class C	Active
Anti-PR3 IgG CLIA Microparticles	CMQ1508	EUDAMED	Class B	Active
CA19-9 CLIA Microparticles	CMB0807	EUDAMED	Class C	Active
CMV IgM CLIA Microparticles	CMK0205	EUDAMED	Class C	Active
Anti-β2-GP1 IgM CLIA Microparticles	CMQ3205	EUDAMED	Class C	Active
rT3 CLIA Microparticles	CME1105	EUDAMED	Class B	Active
IGF-1 CLIA Microparticles	CML0102	EUDAMED	Class B	Active
AutoLumo CA19-9 Calibrators	CA060401	EUDAMED	Class C	Active
CA125 CLIA Microparticles	CMB0601	EUDAMED	Class C	Active
HS-cTnT CLIA Microparticles	CMH0603	EUDAMED	Class C	Active
ProGRP CLIA Microparticles	CMB1905	EUDAMED	Class C	Active
AutoLumo Anti-SS-A/Ro IgG Calibrators	CA010803	EUDAMED	Class B	Active

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