Uti-Tect, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Uti-Tect, Inc. makes
Uti-Tect, Inc. manufactures rapid diagnostic tests for urinary tract infections and neonatal screening, including the GC-TECT (for *Neisseria gonorrhoeae*), B-STREP-TECT-II (for group B streptococcus), and SENSI-TECT (for bacterial sensitivity testing). These devices provide point-of-care or laboratory results to support infection detection and antimicrobial susceptibility assessment.
The company’s products are regulated under FDA’s Class I and Class II classifications, with some devices authorised via the 510(k) pathway. They are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Gc-Tect Ref K840159
Regimes: 510(k) Registry: 510(k)B-Strep-Tect-Ii Ref K840160
Regimes: 510(k) Registry: 510(k)Sensi-Tect Ref K812581
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Uti-Tect, Inc. have in the registry?
The registry currently lists 3 devices for Uti-Tect, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Uti-Tect, Inc.'s devices?
Among its 3 most recently registered devices, Uti-Tect, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Uti-Tect, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Uti-Tect, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Uti-Tect, Inc. in the registry?
The most recently registered devices listed for Uti-Tect, Inc. include GC-TECT, B-STREP-TECT-II and SENSI-TECT.