Flexsite Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Flexsite Diagnostics, Inc. makes
Flexsite Diagnostics, Inc. manufactures blood and urine collection kits for diagnostic testing, including the EZCHEK/HBA Blood Collection Kit and the URISITE Urine Collection Kit for microalbumin/creatinine assessments.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These kits are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Ezchek/Hba Blood Collection Kit Ref K971919
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Flexsite Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Flexsite Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flexsite Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Flexsite Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Flexsite Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Flexsite Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Flexsite Diagnostics, Inc. in the registry?
The most recently registered devices listed for Flexsite Diagnostics, Inc. include EZCHEK/HBA BLOOD COLLECTION KIT and URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING.