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Hangzhou Alltest Biotech.Co.,Ltd.

China·CN-MF-000010710

Last updated September 17, 2026

Information

Country: China
Address: #550, Yinhai Street, Hangzhou, China
Website: alltests.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yan Zhang
EUDAMED SRN: CN-MF-000010710
FDA FEI Number: 3012073813
DUNS Number: —

Catalogue (597)

Page 2 of 12

Device	Model / Reference	Registries	Class	Status
Chlamydia Rapid Test	ICH-N502HJ-02	EUDAMED	Class C	Active
Chlamydia Rapid Test	ICH-502	EUDAMED	IVD Annex II List B	Active
Ethyl Glucuronide(ETG)Rapid Test	DET-N111-50	EUDAMED	Class B	Active
Ethyl Glucuronide(ETG)Rapid Test	DET-N101-50	EUDAMED	Class B	Active
Fluorescence Immunoassay Analyzer	AFR-903	EUDAMED	Class A	Active
hCG Pregnancy Enhanced Sensitivity Rapid Test	FHC-U102	EUDAMED	IVD General	Active
Chlamydia Rapid Test	ICH-N502FH-02	EUDAMED	Class C	Active
Fluorescence Immunoassay Analyzer	AFR-601	EUDAMED	Class A	Active
Prostate- Specific Antigen (PSA) Rapid Test	TPS-NQ402H-01B	EUDAMED	Class C	Active
Chlamydia Rapid Test	ICH-N502MHJ-02	EUDAMED	Class C	Active
Pregabalin(PGB) Rapid Test	DPG-N111B-25	EUDAMED	Class B	Active
Chlamydia Rapid Test	ICH-N502FH-01	EUDAMED	Class C	Active
Chlamydia Rapid Test	ICH-N502MH-01	EUDAMED	Class C	Active
Ethyl Glucuronide(ETG)Rapid Test	DET-N102-25	EUDAMED	Class B	Active
Pregabalin(PGB) Rapid Test	DPG-N111B-50	EUDAMED	Class B	Active
Urine Analyzer	AUR-501	EUDAMED	Class A	Active
Strep B Rapid Test Dipstick Cardiac Troponin T Test Cassette	ISB-501	EUDAMED	IVD General	Active
Prueba Rápida de HBsAg en Casete	IHBSG-402	EUDAMED	IVD Annex II List A	Active
Vitamin D Rapid Test Cassette	OVD-402H	EUDAMED	IVD devices for self-testing	Active
Chlamydia Rapid Test	ICH-N502MHJ-01	EUDAMED	Class C	Active
Ethyl Glucuronide(ETG)Rapid Test	DET-N111B-25	EUDAMED	Class B	Active
Fluorescence Immunoassay Analyzer	AFR-101	EUDAMED	Class A	Active
Precision DX Multi-Panel Drug Test Card	1	FDA UDI	Class II	Active
Shinetell Digital Pregnancy Test	1	FDA UDI	Class II	Active
Precision DX Multi-Panel Drug Test Card	1	FDA UDI	Class II	Active
CLIA waived, Inc. Rapid Drug Test Device “RDTD” for Fentanyl in Urine	DFY-A102C	FDA UDI	Class II	Active
Discover	DISP-DUD6144N$	FDA UDI	Class II	Active
Multi-Drug 14 Drugs Rapid Test Cup	1	FDA UDI	Class II	Active
FirstCheck HOME DRUG TEST	1	FDA UDI	Class II	Active
Discover milti-drug 8 drugs rapid test cup (urine)	DUA-A187C-A3 A1617	FDA UDI	Class II	Active
Alltest Multi-Drug 12 Drugs Rapid Test Cup	1	FDA UDI	Class II	Active
Alltest	DFY-A102H	FDA UDI	Class II	Active
One Step One Step FSH Urine test strip	1	FDA UDI	Class I	Active
Alltest	DFY-A102H	FDA UDI	Class II	Active
Alltest Pregnancy Rapid Test	1	FDA UDI	Class II	Active
Discover	DISP-CUP164N$	FDA UDI	Class II	Active
Identify Fentanyl Rapid Cassette	DFY-A102C A3218	FDA UDI	Class II	Active
Discover	DISP-CLIAFEN$	FDA UDI	Class II	Active
Alltest Pregnancy Rapid Test	1	FDA UDI	Class II	Active
Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine)	1	FDA UDI	Class II	Active
Alltest	DFY-A102C	FDA UDI	Class II	Active
Discover Multi-Drug 8 Drugs Rapid Test Cup(Urine)	1	FDA UDI	Class II	Active
Alltest	121151-1-44	FDA UDI	Class II	Active
Alltest Multi-Drug 14 Drugs Rapid Test Cup	1	FDA UDI	Class II	Active
AllTest	DFY-A102C (1ng)	FDA UDI	Class II	Active
Discover Multi-Drug 5 Drugs Rapid Urine Test Cup	1	FDA UDI	Class II	Active
AllTest Fentanyl Rapid Test (Urine)	DFY-A102	FDA UDI	Class II	Active
Multi-Drug 12 Drugs Rapid Test Cup	1	FDA UDI	Class II	Active
Discover milti-drug 7 drugs rapid test cup	DUA-A177C-A3 A1617	FDA UDI	Class II	Active
FirstCheck HOME DRUG TEST	1	FDA UDI	Class II	Active

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Hangzhou AllTest Biotech Co., Ltd Hangzhou Zhejiang · CN FEI 3043127647