Data / Medical devices / China / Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. is registered with the FDA (registration 3017231634) in Hangzhou Zhejiang, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017231634
- Address
- #139 10th Street (East) Hangzhou Economic and Technology Development Zone, Hangzhou Zhejiang, China, 310018
- Owner or operator
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. (10078538)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 26, 2020
- Registered through
- 2026
- Brand names listed
- Disposable sampling swab, Genesis Sampling Swab, KaiBiLi Extended ViralTrans, KaiBiLi Extended ViralTrans PBS, KaiBiLi Extended ViralTrans Saline, KaiBiLi Saliva Collection Kit, OC-Light S FIT, Vaginal Swab Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| December 21, 2023 | K231027 | KaiBiLi Extended ViralTrans | JSM | Substantially Equivalent | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Reagent, Occult Blood
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of Container, Specimen, Sterile
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Culture Media, Non-Propagating Transport
Updated December 21, 2023. 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.