Bioteke Corporation (Wuxi) Co., Ltd.
Manufacturer and brand owner in Wuxi, Jiangsu, China. 21 device types, 5 products catalogued, 1 clearance.
Bioteke Corporation (Wuxi) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers General Purpose Reagent, Control, Fecal Occult Blood and 19 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
21device types registered with the FDA
5products catalogued under its own name
1510(k) clearance
Registration
| Registered name | BIOTEKE CORPORATION (WUXI) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016837106 |
| FEI number | 3016837106 |
| DUNS | 560011452 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 无锡百泰克生物技术有限公司 |
|---|---|
| Unified social credit code | 913202065617502076 |
| Source | NMPA UDI database |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | No. 90, Huiming Road, Huishan |
| Postal code | 214000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | Class 1 | Fast real-time fluorescence PCR analyzer, real-time fluorescent quantitative PCR instrument | 2021 | 9 |
| Antigen, Id, Candida Albicans | Class 2 | Candida Albicans/Trichomonas Vaginalis Antigen Rapid Test Kit (Immunochromatographic Assay), Candida Albicans Antigen Rapid Test Kit (Immunochromatographic Assay) | 2023 | 1 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Disposable Sampling Swab, Disposable sterile sampling swab | 2020 | 100 |
| Clinical Sample Concentrator | Class 1 | Nucleic Acid Extraction Kit, Automated Nucleic Acid Extraction System | 2020 | 27 |
| Container, Specimen Mailer And Storage, Sterile | Class 1 | Disposable Virus Sampling Swab Kits | 2021 | 33 |
| Container, Specimen, Non-Sterile | Class 1 | Disposable virus sampling Swab kits | 2020 | 115 |
| Container, Specimen, Sterile | Class 1 | Disposable Specimen Container | 2020 | 79 |
| Control, Fecal Occult Blood | Class 2 | Fecal Occult Blood (FOB) Rapid Test Kit (Immunochromatographic Assay) | 2023 | 3 |
| Coronavirus Antigen Detection Test System. | Class N | Bio-Self COVID-19 Antigen Home Test | 2023 | 12 |
| Culture Media, Non-Propagating Transport | Class 1 | Sterile Disposable Virus Sampling Kits | 2022 | 11 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Disposable Virus Sampling Swab Kits, Sample Preservation Swab Kits | 2021 | 18 |
| Culture Media, Single Biochemical Test | Class 1 | Disposable specimen collection kit | 2023 | 2 |
| Dna Probe, Trichomonas Vaginalis | Class 1 | Trichomonas Vaginalis Antigen Rapid Test Kit (Immunochromatographic Assay) | 2023 | 1 |
| General Purpose Reagent | Class 1 | Nucleic Acid Release Reagent, Nucleic Acid Release Reagent (free extraction) | 2020 | 30 |
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | Class 1 | Insulin-like Growth Factor Binding Protein-1 Rapid Test Kit (Colloidal Gold Method) | 2023 | 4 |
| Kit, Identification, Neisseria Gonorrhoeae | Class 1 | Neisseria Gonorrhoeae Antigen Rapid Test Kit (Immunochromatographic Assay) | 2023 | 2 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | Luteinizing Hormone (LH) Rapid Test Kit (Immunochromatographic Assay) | 2023 | 16 |
| Real Time Nucleic Acid Amplification System | Class 2 | Automatic Nucleic Acid Detection System | 2020 | 15 |
| Sperm, Antigen, Antiserum, Control | Class 1 | Sperm SP10 Protein Rapid Test Kit (Immunochromatographic Assay) | 2023 | 5 |
| Station, Pipetting And Diluting, For Clinical Use | Class 1 | Automated Sample Transfer Processing System | 2022 | 5 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | Follicle-stimulating Hormone (FSH) Rapid Test Kit (Immunochromatographic Assay) | 2023 | 30 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211707 | 2022-05-04 | JSM | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Employees | 600 |
| Factory area | 50000 |
| Main products | Respiratory rapid tests, Pregnancy tests, Infectious disease detection, PCR kits, RNA extraction systems |
| Certifications | ISO13485, ISO9001, CE-IVDR, GMP, FDA |
| Export markets | 100+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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