Bioteke Corporation (Wuxi) Co., Ltd
Wuxi City Jiangsu, CN
BIOTEKE CORPORATION (WUXI) CO., LTD appears in FDA device records in Wuxi City Jiangsu, CN. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Bioteke Corporation (Wuxi) Co., Ltd in 2022.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016837106 | 3016837106 | BIOTEKE CORPORATION (WUXI) CO., LTD | No. 90, Huiming Road, Huishan, Wuxi City Jiangsu 214000 CN | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- LHKAntigen, Id, Candida Albicans
- KXGApplicator, Absorbent Tipped, Sterile
- JJHClinical Sample Concentrator
- KDTContainer, Specimen Mailer And Storage, Sterile
- NNIContainer, Specimen, Non-Sterile
- FMHContainer, Specimen, Sterile
- OSLControl, Fecal Occult Blood
- QKPCoronavirus Antigen Detection Test System.
- JSMCulture Media, Non-Propagating Transport
- JSGCulture Media, Non-Selective And Non-Differential
- JSFCulture Media, Single Biochemical Test
- MJKDna Probe, Trichomonas Vaginalis
- PPMGeneral Purpose Reagent
- OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-1
- JSXKit, Identification, Neisseria Gonorrhoeae
- CEPRadioimmunoassay, Luteinizing Hormone
- OOIReal Time Nucleic Acid Amplification System
- DFQSperm, Antigen, Antiserum, Control
- JQWStation, Pipetting And Diluting, For Clinical Use
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain