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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 3 of 5

Device	Model / Reference	Registries	Class	Status
IgE Serum Test	R14-112	EUDAMED	IVD General	Active
Glucose/Ketone Test	U02-002	EUDAMED	IVD General	Active
H.pylori Serum Test	R18-110	EUDAMED	IVD General	Active
EDDP Test	R61-110	EUDAMED	IVD General	Active
Malaria Whole Blood (pv) Test	R11-116	EUDAMED	IVD General	Active
Morphine/Heroin/Opiate Test	R28-112	EUDAMED	IVD General	Active
Semi-quantitative AFP Serum/Whole Blood Test	SQ00-116	EUDAMED	IVD General	Active
Covid-19-Ag Panel Rapid test	R191-112	EUDAMED	IVD General	Active
MultiDrugs-7 Test panel	R153-700	EUDAMED	IVD General	Active
H. Pylori Latex Antigen Stool Test	R109-112	EUDAMED	IVD General	Active
2000 mIU/ml hCG Urine Test	R05-110	EUDAMED	IVD General	Active
Methamphetamine Test	R26-110	EUDAMED	IVD General	Active
Fecal Occult Blood Rapid Test	R40-112	EUDAMED	IVD devices for self-testing	Active
Legionella Pneumophila Test	R19-112	EUDAMED	IVD General	Active
Early Pregnancy (hCG) Test	R04-114	EUDAMED	IVD devices for self-testing	Active
h-FABP Test	R183-116	EUDAMED	IVD General	Active
Dengue IgG Serum Test	R84-112	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel L	R153-300L	EUDAMED	IVD General	Active
Fecal Occult Blood Test	B00-630	EUDAMED	IVD General	Active
PCP Test	R31-110	EUDAMED	IVD General	Active
TSH Serum Test	R72-112	EUDAMED	IVD General	Active
MultiDrugs-6 Test panel	R153-600	EUDAMED	IVD General	Active
Bone Marker Test	B02-112	EUDAMED	IVD General	Active
MultiDrugs-3 Test panel N	R153-300N	EUDAMED	IVD General	Active
Strep A Test	R34-110	EUDAMED	IVD General	Active
H.pylori Serum Test	R18-112	EUDAMED	IVD General	Active
hCG Pregnancy Urine Test, Sensitivity 5 mIU	R04-514	EUDAMED	IVD General	Active
hCG Pregnancy Urine Test, Sensitivity 20 mIU	R04-112	EUDAMED	IVD General	Active
Vaginitis panel Test	W0105090199	EUDAMED	IVD General	Active
Dengue IgG Serum Test	R84-110	EUDAMED	IVD General	Active
MDMA Test	R41-110	EUDAMED	IVD General	Active
OB complex Combo Test	R43-112	EUDAMED	IVD General	Active
Candida Cassette Test	R36-112	EUDAMED	IVD General	Active
2000 mIU/ml hCG Urine Test	R05-112	EUDAMED	IVD General	Active
Rota/Adeno Test	R95-112	EUDAMED	IVD General	Active
Oxycodone Test	R51-112	EUDAMED	IVD General	Active
MultiDrugs-6 Test panel B	R153-600B	EUDAMED	IVD General	Active
Troponin I Whole Blood/Serum Test	R22-112	EUDAMED	IVD General	Active
Semi-quantitative CEA Serum/Whole Blood Test	SQ20-116	EUDAMED	IVD General	Active
MultiDrugs-5 Test panel B	R153-500B	EUDAMED	IVD General	Active
Covid-19-Ag Rapid test	R190-112	EUDAMED	IVD General	Active
Rheumatoid Factor (RF) Serum Test	R15-112	EUDAMED	IVD General	Active
Malaria Whole Blood (pf) Test	R10-110	EUDAMED	IVD General	Active
Semi-quantitative Albumin Urine Test	SQ50-110	EUDAMED	IVD General	Active
Cotinine Test	R152-112	EUDAMED	IVD General	Active
hCG Pregnancy Urine Test, Sensitivity 20 mIU	R04-100	EUDAMED	IVD General	Active
Fecal Occult Blood Test	B00-610	EUDAMED	IVD General	Active
hCG Pregnancy Urine/Serum Test	R06-100	EUDAMED	IVD General	Active
Oxycodone Test	R51-110	EUDAMED	IVD General	Active
hCG Pregnancy Urine Test, Sensitivity 20 mIU	R04-N-104	EUDAMED	IVD General	Active

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