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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 8 of 9

Device	Model / Reference	Registries	Class	Status
Lytic Anaerobic Culture Bottle	MC0502	EUDAMED	Class A	Active
w22 CLIA Microparticles	CMQA2402	EUDAMED	Class B	Active
AMA-M2 IgG CLIA Microparticles	CMQ2410	EUDAMED	Class B	Active
Wash Buffer	CMO0303	EUDAMED	Class A	Active
CMV IgM CLIA Microparticles	CMK0203	EUDAMED	Class C	Active
TSH CLIA Microparticles	CME0302	EUDAMED	Class B	Active
B19 IgM CLIA Microparticles	CMK1210	EUDAMED	Class C	Active
AutoLumo Anti-CL IgA Calibrators	CA013403	EUDAMED	Class C	Active
Diluent Universal	CMO0201	EUDAMED	Class A	Active
ACTH CLIA Microparticles	CMD0201	EUDAMED	Class B	Active
Anti-Sm IgG CLIA Microparticles	CMQ2003	EUDAMED	Class B	Active
SHBG CLIA Microparticles	CMF0803	EUDAMED	Class B	Active
AutoLumo Anti-PR3 IgG Calibrators	CA011703	EUDAMED	Class B	Active
f3 CLIA Microparticles	CMQA0702	EUDAMED	Class B	Active
CEA CLIA Microparticles	CMB0205	EUDAMED	Class C	Active
Anti-Scl-70 IgG CLIA Microparticles	CMQ1803	EUDAMED	Class B	Active
Sample Pretreatment Reagent	MSA01	EUDAMED	Class A	Active
AutoLumo H-FABP Calibrators	CA140601	EUDAMED	Class C	Active
ToRCH IgM Control	ZKB0402	EUDAMED	Class C	Active
NT-proBNP CLIA Microparticles	CMH0403	EUDAMED	Class C	Active
Toxo IgG CLIA Microparticles	CMK0602	EUDAMED	Class C	Active
Vitamin B12 CLIA Microparticles	CMS0305	EUDAMED	Class B	Active
RF CLIA Microparticles	CMQ1010	EUDAMED	Class B	Active
CYFRA 21-1 CLIA Microparticles	CMB1205	EUDAMED	Class C	Active
AutoLumo Anti-β2-GP1 IgG Calibrators	CA012703	EUDAMED	Class C	Active
Anti-Ribosomal P IgG CLIA Microparticles	CMQ2203	EUDAMED	Class B	Active
Anti-β2-GP1 IgG CLIA Microparticles	CMQ3110	EUDAMED	Class C	Active
Anti-sp100 IgG CLIA Microparticles	CMQ2610	EUDAMED	Class B	Active
Anti-TG CLIA Microparticles	CME0608	EUDAMED	Class B	Active
Anti-Ro-52 IgG CLIA Microparticles	CMQ0805	EUDAMED	Class B	Active
ToRCH IgG Control	ZKA0202	EUDAMED	Class C	Active
G-17 CLIA Microparticles	CMB2110	EUDAMED	Class B	Active
17α-OHP CLIA Microparticles	CMF0905	EUDAMED	Class B	Active
IGF-1 CLIA Microparticles	CML0101	EUDAMED	Class B	Active
Gram Negative bacteria ID/AST	ME0201	EUDAMED	Class C	Active
AutoLumo sIgE Calibrators	CA010303	EUDAMED	Class B	Active
AMA-M2 IgG CLIA Microparticles	CMQ2405	EUDAMED	Class B	Active
E2 CLIA Microparticles	CMF0505	EUDAMED	Class B	Active
RF CLIA Microparticles	CMQ1003	EUDAMED	Class B	Active
AutoLumo HER-2/neu CLIA Microparticles	CA062201	EUDAMED	Class C	Active
Anti-CL IgG CLIA Microparticles	CMQ3503	EUDAMED	Class C	Active
CA72-4 CLIA Microparticles	CMB1407	EUDAMED	Class C	Active
TRAb CLIA Microparticles	CME1001	EUDAMED	Class B	Active
RF IgM CLIA Microparticles	CMQ1105	EUDAMED	Class B	Active
Cortisol CLIA Microparticles	CMD0302	EUDAMED	Class C	Active
Sputum Processing Reagent	AS030103	EUDAMED	Class A	Active
Endocrine Control II	ZKE0301	EUDAMED	Class C	Active
MYO CLIA Microparticles	CMH0103	EUDAMED	Class C	Active
Calcitonin CLIA Microparticles	CMS0605	EUDAMED	Class C	Active
Gram Positive bacteria ID	ME0502	EUDAMED	Class C	Active

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