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Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

China·CN-MF-000020607

Last updated June 8, 2026

Information

Country: China
Address: K4-2 Science Technology Garden, Economic Development Zone, Tongxiang, Zhejiang, China
Website: ameritek.org
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Xiangdong Chen
EUDAMED SRN: CN-MF-000020607
FDA FEI Number: —
DUNS Number: —

Catalogue (210)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
hCG Panel Test	R04-140	EUDAMED	IVD devices for self-testing	Active
Albumin Urine-Simple Test	R55-112	EUDAMED	IVD General	Active
MultiDrugs-8 Test panel	R153-800	EUDAMED	IVD General	Active
Femlab Test	V02-512	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel C	R153-300C	EUDAMED	IVD General	Active
Rotavirus Test	R93-112	EUDAMED	IVD General	Active
E.Coli Test	R104-112	EUDAMED	IVD General	Active
Bladder Cancer Marker Test	R01S-112	EUDAMED	IVD General	Active
MultiDrugs-12 Test panel	R153-1200	EUDAMED	IVD General	Active
M.Tuberculosis Combo serum Test	R09-C-110	EUDAMED	IVD General	Active
Dengue NS1 Test	R330-112	EUDAMED	IVD General	Active
H. Pylori Ag Stool Test	R108-112	EUDAMED	IVD General	Active
Mononucleosis(IgM) Whole Blood/Serum Test	R70-116	EUDAMED	IVD General	Active
BZD Test	R27-110	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel D	R153-300D	EUDAMED	IVD General	Active
Adenovirus Test	R94-112	EUDAMED	IVD General	Active
Candida Strip Test	R36-110	EUDAMED	IVD General	Active
AFP Serum/Whole Blood Test	R00-116	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel A	R153-300A	EUDAMED	IVD General	Active
SALMONELLA Test	R106-110	EUDAMED	IVD General	Active
Legionella Pneumophila Test	R19-110	EUDAMED	IVD General	Active
Trichomonus Test	R97-112	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel G	R153-300G	EUDAMED	IVD General	Active
BZD Test	R27-112	EUDAMED	IVD General	Active
MultiDrugs-10Test panel	R153-1000	EUDAMED	IVD General	Active
Influenza Test	R89-112	EUDAMED	IVD General	Active
Glu/Ket/PH/Blood/Pro/Bili/Urobil Test	U02-007	EUDAMED	IVD General	Active
Glucose/Ketone/PH Test	U02-003	EUDAMED	IVD General	Active
Cocaine Test	R24-110	EUDAMED	IVD General	Active
BAR Test	R25-110	EUDAMED	IVD General	Active
CRP Whole Blood/Serum Test	SQ182-116	EUDAMED	IVD General	Active
TB Combo Test	R09-C-112	EUDAMED	IVD General	Active
The new generation OB Test	R402-112	EUDAMED	IVD General	Active
M.Tuberculosis Whole Blood/Serum Test	R09-116	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel M	R153-300M	EUDAMED	IVD General	Active
MultiDrugs-5 Test panel D	R153-500D	EUDAMED	IVD General	Active
Glucose Test	U02-001	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel F	R153-300F	EUDAMED	IVD General	Active
MultiDrugs-10 Test panel E	R153-1000E	EUDAMED	IVD General	Active
Gonorrhea Test	R300-112	EUDAMED	IVD General	Active
Chlamydia Trachomatis Test	R16-110	EUDAMED	IVD Annex II List B	Active
M.Tuberculosis Combo Whole Blood/Serum Test	R09-C-116	EUDAMED	IVD General	Active
Malaria Whole Blood (pv) Test	R11-110	EUDAMED	IVD General	Active
Alcohol Strip Test	R107-110	EUDAMED	IVD General	Active
MultiDrugs-10 Test panel B	R153-1000B	EUDAMED	IVD General	Active
Early Pregnancy (hCG) Test	R04-120	EUDAMED	IVD devices for self-testing	Active
Eddp	R61-112	EUDAMED	IVD General	Active
Creatinine Albumin Test	CA-10	EUDAMED	IVD General	Active
MultiDrugs-6 Test panel C	R153-600C	EUDAMED	IVD General	Active
MultiDrugs-5 Test panel F	R153-500F	EUDAMED	IVD General	Active

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