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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 3 of 12

Device	Model / Reference	Registries	Class	Status
FirstCheck HOME DRUG TEST	1	FDA UDI	Class II	Active
FOB Rapid Test Cassette	TFO-602	FDA UDI	Class II	Active
AllTest Fentanyl Rapid Test (Urine)	DFY-A102	FDA UDI	Class II	Active
Alltest hCG Early Pregnancy Rapid Test	1	FDA UDI	Class II	Active
Identify Fentanyl Rapid Cassette	DFY-A102H A3218	FDA UDI	Class II	Active
Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)	1	FDA UDI	Class II	Active
iScreen Urine Test DX Drug Screen Tox Cup	DUA-A1147C	FDA UDI	Class II	Active
Multi-Drug 14 Drugs Rapid Test Cup	1	FDA UDI	Class II	Active
Cotinine (COT) Rapid Test Cassette	DCT-102	FDA UDI	Class I	Active
Discover Multi-Drug 9 Drugs Rapid Test Cup(Urine)	1	FDA UDI	Class II	Active
DrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup	1	FDA UDI	Class II	Active
Discover milti-drug12 drugs rapid test cup	DUA-A1127C-A3 A1617	FDA UDI	Class II	Active
Discover Fentanyl Rapid Tes Cassette	DFY-A102H A1617	FDA UDI	Class II	Active
FirstCheck Cotinine Oral Fluid Test	1	FDA UDI	Class I	Active
One Step FSH Urine midstream Test	1	FDA UDI	Class I	Active
Multi-Drug 13 Drugs Rapid Test Cup	1	FDA UDI	Class II	Active
Cotinine (COT) Rapid Test Dipstick	DCT-101	FDA UDI	Class I	Active
FirstCheck HOME DRUG TEST	1	FDA UDI	Class II	Active
2SAN Fentanyl Rapid Tes Cassette	DFY-A102H A2553	FDA UDI	Class II	Active
Cotinine (COT) Rapid Test Panel	DCT-114	FDA UDI	Class I	Active
Syphilis Rapid Test	ISY-N402	EUDAMED	Class C	Active
FOB Rapid Test Cassette	TFO-602H	EUDAMED	IVD devices for self-testing	Active
Ferritin Rapid Test Cassette	OFE-402H	EUDAMED	IVD devices for self-testing	Active
FSH Rapid Test Midstream	FFS-103H	EUDAMED	IVD devices for self-testing	Active
H. pylori Antigen Rapid Test cassette	IHP-602H	EUDAMED	IVD devices for self-testing	Active
Pregnancy (hCG) Rapid Test Midstream	FHC-103H	EUDAMEDFDA UDI	IVD devices for self-testing	Active
Dry-type Fluorescent Immunoassay Analyzer (Single channel)	AFR-600	EUDAMED	Class A	Active
Hb Hemoglobin Test Meter	AHR-100ST	EUDAMED	Class A	Active
Ferritin Rapid Test Cassette	OFE-402H	EUDAMED	IVD devices for self-testing	Active
Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette	CMA-435	EUDAMED	IVD General	Active
Dengue NS1 Rapid Test Cassette	IDES-402	EUDAMED	IVD General	Active
Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I	AGKUCR-100	EUDAMED	Class A	Active
CA15-3 Rapid Test Cassette	T153-402	EUDAMED	IVD General	Active
MONO Rapid Test	IMO-N402B-25	EUDAMED	Class C	Active
Test ciążowy płytkowy 2 sztuki Szybki test ciążowy hCG o zwiększonej czułości (z moczu)	FHC-U102H	EUDAMED	IVD devices for self-testing	Active
Rotavirus Rapid Test	IRO-N602J-25	EUDAMED	Class B	Active
FOB Rapid Test	TFO-N601B-25	EUDAMED	Class B	Active
Salmonella typhi Antigen Rapid Test Cassette	ISTY-602	EUDAMED	IVD General	Active
Malaria P.f. /P.v. Rapid Test	IMPV-N402B-25	EUDAMED	Class C	Active
Schnelltest Eisen	600801	EUDAMED	IVD devices for self-testing	Active
HbA1c Rapid Test Cassette	OHA-402	EUDAMED	IVD General	Active
Dengue NS1 Rapid Test	IDES-N402B-25	EUDAMED	Class C	Active
Urine Analyzer	AUR-500	EUDAMED	Class A	Active
LH Ovulation Rapid Test Dipstick	FLH-101H	EUDAMED	IVD devices for self-testing	Active
Norovirus Rapid Test Cassette (Feces)	INO-602	EUDAMED	IVD General	Active
Adenovirus Rapid Test	IAD-N602J-25	EUDAMED	Class B	Active
SAA and CRP Combo Rapid Test Cassette	OCSC-425	EUDAMED	IVD General	Active
MONO Rapid Test	IMO-N402J-25	EUDAMED	Class C	Active
FOB Rapid Test	TFO-N601J-25	EUDAMED	Class B	Active
Vitamin-D-Schnelltestkassette	OVD-402H	EUDAMED	IVD devices for self-testing	Active

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