Zhejiang Gene Science Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Zhejiang Gene Science Co., Ltd. makes
Zhejiang Gene Science Co., Ltd. manufactures sample preservation solutions designed for maintaining biological specimens during storage and transport.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
Sample preservation solution Ref K212878
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 415610563
FDA establishments
- Zhejiang Gene Science Co., Ltd shaoxing Zhejiang · CN FEI 3016764932
Frequently asked questions
How many devices does Zhejiang Gene Science Co., Ltd. have in the registry?
The registry currently lists 3 devices for Zhejiang Gene Science Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zhejiang Gene Science Co., Ltd.'s devices?
Among its 3 most recently registered devices, Zhejiang Gene Science Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Zhejiang Gene Science Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Zhejiang Gene Science Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zhejiang Gene Science Co., Ltd. in the registry?
The most recently registered devices listed for Zhejiang Gene Science Co., Ltd. include ZHEJIANG GENE SCIENCE 3.0 mL/tube;100pcs/Tray, 15 Trays/Box, ZHEJIANG GENE SCIENCE 2.0 mL/tube;100pcs/Tray, 15 Trays/Box and Sample preservation solution.
Which FDA establishments are linked to Zhejiang Gene Science Co., Ltd.?
1 FDA establishment is linked to Zhejiang Gene Science Co., Ltd. in the registry; they are listed on the company page.