Data / Medical devices / China / Bioteke Corporation (wuxi) Co., Ltd

Bioteke Corporation (wuxi) Co., Ltd: FDA-registered device maker in Wuxi City Jiangsu, China, 2 510(k) clearances

Name: Bioteke Corporation (wuxi) Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bioteke Corporation (wuxi) Co., Ltd is registered with the FDA (registration 3016837106) in Wuxi City Jiangsu, China. It lists 31 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016837106
Address: No. 90, Huiming Road, Huishan, Wuxi City Jiangsu, China, 214000
Owner or operator: BioTeke Corporation (Wuxi) Co., Ltd (10071745)
Roles: Exporter to the US, Manufacturer
First device listed: April 23, 2020
Registered through: 2026
Brand names listed: Automated Nucleic Acid Extraction System, Automated Sample Transfer Processing System, Automatic Nucleic Acid Detection System, Bio-Self COVID-19 Antigen Home Test, BioTeke® Multi-Drug Urine Test Cup, Candida Albicans Antigen Rapid Test Kit (Immunochromatographic Assay), Candida Albicans/Trichomonas Vaginalis Antigen Rapid Test Kit (Immunochromatographic Assay), Disposable Sampling Swab and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	JJC	1	Manufacturer	accessdata.fda.gov
Antigen, Id, Candida Albicans	LHK	2	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer	accessdata.fda.gov
Control, Fecal Occult Blood	OSL	2	Manufacturer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Manufacturer	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Culture Media, Non-Selective And Non-Differential	JSG	1	Manufacturer	accessdata.fda.gov
Culture Media, Single Biochemical Test	JSF	1	Manufacturer	accessdata.fda.gov
Dna Probe, Trichomonas Vaginalis	MJK	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Immunoassay, Insulin-Like Growth Factor Binding Protein-1	OAM	1	Manufacturer	accessdata.fda.gov
Kit, Identification, Neisseria Gonorrhoeae	JSX	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer	accessdata.fda.gov
Sperm, Antigen, Antiserum, Control	DFQ	1	Manufacturer	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Manufacturer	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Manufacturer	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Manufacturer	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Manufacturer	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Manufacturer	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Manufacturer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Manufacturer	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Manufacturer	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Manufacturer	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Manufacturer	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Manufacturer	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 10, 2026	K261409	BioTeke® Multi-Drug Urine Test Cup	NFT	Substantially Equivalent	Bioteke Corporation (Wuxi) Co., Ltd.	accessdata.fda.gov
May 4, 2022	K211707	BioTeke Sterile Disposable Virus Sampling Kit	JSM	Substantially Equivalent	Bioteke Corporation (Wuxi) Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.