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Bioteke Corporation (Wuxi) Co., Ltd.

China·CN-MF-000007517

Last updated May 27, 2026

What Bioteke Corporation (Wuxi) Co., Ltd. makes

Bioteke Corporation produces in vitro diagnostic (IVD) devices for clinical and self-testing applications, including general specimen collection kits for laboratory use, nucleic acid extraction and isolation kits, and dedicated instruments for sample preparation. Their portfolio also includes rapid immunochromatographic test kits for SARS-CoV-2 antigen detection, saliva-based pregnancy tests, and hormone assays like follicle-stimulating hormone (FSH) tests, alongside consumables for nucleic acid processing.

The company’s devices are classified under IVD General, Class A, Class C, and Class I categories, with regulatory listings in the EU’s EUDAMED database, the FDA’s 510(k) and UDI registries. The manufacturer operates from Wuxi, China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: China
Address: No. 90, Huiming Road, Huishan, Wuxi City, Jiangsu, 214000, China, Wuxi, China
Website: www.bioteke.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 （0510）8332 3992
PRRC Contact: Guoqiang Zhang
EUDAMED SRN: CN-MF-000007517
FDA FEI Number: —
DUNS Number: 560011452

Catalogue (97)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Fast Real-time Fluorescence PCR Analyzer	BTK-1	EUDAMED	Class A	Active
Reaction sample well	BTK-8-B10-10-00	EUDAMED	Class A	Active
Saliva Pregnancy Test Kit	ICA2235	EUDAMED	IVD General	Active
Reaction sample well	BTK-E04-B1-25-00	EUDAMED	Class A	Active
Nucleic Acid Release Reagent (free extraction)	ZK1500	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	AU1812	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	AU18012	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	AU18012-96	EUDAMED	Class A	Active
Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)	ICA2229	EUDAMED	IVD General	Active
Consumables for Nucleic Acid Extraction	AU1001-5	EUDAMED	Class A	Active
Saliva Pregnancy Test Kit	ICA2235	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	DP4613	EUDAMED	Class A	Active
Reaction sample well	BTK-E04-B1-40-00	EUDAMED	Class A	Active
Pipette	PT100	EUDAMED	Class A	Active
Pipette	PTE50	EUDAMED	Class A	Active
Pipette	PTE200	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	AU17011	EUDAMED	Class A	Active
ollicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)	ICA2229	EUDAMED	IVD General	Active
Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)	ICA2230	EUDAMED	IVD General	Active
Human Papillomavirus (HPV) Genotyping Detection Kit (Fluorescence PCR Method)	PR2026-HP04	EUDAMED	IVD General	Active
Human Papillomavirus (HPV) Genotyping Detection Kit (Fluorescence PCR Method)	PR2026-HP04	EUDAMED	IVD General	Active
Pipette	PT10	EUDAMED	Class A	Active
Consumables for Nucleic Acid Extraction	AU1001-2	EUDAMED	Class A	Active
Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)	PR2024-UT01	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	AU52111	EUDAMED	Class A	Active
Reaction sample well	BTK-E02-B48-20-00	EUDAMED	Class A	Active
Reaction sample well	BTK-8-B4-10-00	EUDAMED	Class A	Active
Reaction sample well	BTK-E04-B1-20-00	EUDAMED	Class A	Active
Pipette	PTE10	EUDAMED	Class A	Active
SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)	ICA2501	EUDAMED	IVD General	Active
Human chorionic gonadotropin (HCG) Rapid Test Kit (Immunochromatographic Assay)	ICA2225	EUDAMED	IVD General	Active
Consumables for Nucleic Acid Extraction	AU1001-3	EUDAMED	Class A	Active
Pipette	PTE100	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	DP4612	EUDAMED	Class A	Active
Human chorionic gonadotropin (HCG) Rapid Test Kit (Immunochromatographic Assay)	ICA2225	EUDAMED	IVD General	Active
SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)	ICA2521	EUDAMED	IVD General	Active
Automated sample transfer processing system	BF4096	EUDAMED	Class A	Active
Human chorionic gonadotropin (HCG) Rapid Test Kit (Immunochromatographic Assay)	ICA2225	EUDAMED	IVD General	Active
Disposable specimen collection kit	ST6001	EUDAMED	Class A	Active
Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)	ICA2230	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	AU1811	EUDAMED	Class A	Active
Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay)	ICA2229	EUDAMED	IVD General	Active
Pipette	PT5000	EUDAMED	Class A	Active
Nucleic Acid Release Reagent (free extraction)	ZK1000	EUDAMED	Class A	Active
Disposable Virus Sampling Swab Kits	ZK1500-1	EUDAMED	Class A	Active
Luteinising Hormone (LH) Rapid Test Kit (Immunochromatographic Assay)	ICA2230	EUDAMED	IVD General	Active
Pipette	PTE300	EUDAMED	Class A	Active
Reaction sample well	BTK-8-B8-10-00	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	AU17012	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	DP4611	EUDAMED	Class A	Active

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