Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016837106

FEI Number

3016837106

Entity Name

BIOTEKE CORPORATION (WUXI) CO., LTD

City/State/Country

Wuxi City Jiangsu, CN

Establishment Address

No. 90, Huiming Road, Huishan, Wuxi City Jiangsu 214000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioTeke Corporation (Wuxi) Co., Ltd (Owner Number: 10071745)

Owner / Operator Contact Address

4th floor, D5, No.1719,Huishan Avenue, Wuxi, CN-JS 214174, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bio-Self COVID-19 Antigen Home Test Disposable Sampling Swab Disposable sterile sampling swab Automated Nucleic Acid Extraction System Nucleic Acid Extraction Kit Disposable specimen collection kit Nucleic Acid Release Reagent Nucleic Acid Release Reagent (free extraction) Candida Albicans Antigen Rapid Test Kit (Immunochromatographic Assay) Candida Albicans/Trichomonas Vaginalis Antigen Rapid Test Kit (Immunochromatographic Assay) Automatic Nucleic Acid Detection System Disposable virus sampling Swab kits Luteinizing Hormone (LH) Rapid Test Kit (Immunochromatographic Assay) real-time fluorescent quantitative PCR instrument Fast real-time fluorescence PCR analyzer Disposable Specimen Container Disposable Virus Sampling Swab Kits Sample Preservation Swab Kits Disposable Virus Sampling Swab Kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2023-06-16
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-05-27
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2020-05-13
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	2023-05-24
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-08-19
LHK	Antigen, Id, Candida Albicans	Microbiology	Class 2	866.3165	2023-06-15
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-09-24
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-04-23
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2023-06-15
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2021-01-28
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-07-16
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2021-04-13
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2021-04-01

Official Correspondent

Zhitu Zhou

US Agent Details

Lee JO Business: E&E High Tech Solution, Inc. Email: info@aspen-usa.com Phone: (626) 2883966

Related Public Records

Same Entity

BioTeke Corporation (Wuxi) Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K822995	Granite Diagnostics, Inc.	ANDRADES FERMENTATION MEDIA	1982-11-16
K880126	Hardy Media	LAURYL TRYPTOSE BROTH	1988-03-31
K821594	Hardy Media	UREA AGAR SLANT	1982-07-08
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Similar Registrations

Registration Number	Establishment Name	Location
3043128348	Shenzhen Yang Biotech Co., Ltd.	Shenzhen Guangdong, CN
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016837106. Last updated year: 2026. Please use registration number 3016837106 when referencing this establishment in official correspondence.