Technalysis, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Technalysis, Inc. makes
Technalysis, Inc. manufactures hematology analyzers, including the CELLEXIS HEMATOLOGY ANALYZER for automated blood cell counting, and the HEMAVIEW DARKFIELD MICROSCOPE SYSTEM for manual blood smear examination. The company also produces the TECHLYTE ELECTROLYTE ANALYZER, a device for measuring electrolyte levels in blood samples.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These instruments are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Cellexis Hematology Analyzer Ref K923773
Regimes: 510(k) Registry: 510(k)Hemaview Darkfield Microscope System Ref K885091
Regimes: 510(k) Registry: 510(k)Techlyte Electrolyte Analyzer Ref K905600
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Technalysis, Inc. have in the registry?
The registry currently lists 3 devices for Technalysis, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Technalysis, Inc.'s devices?
Among its 3 most recently registered devices, Technalysis, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Technalysis, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Technalysis, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Technalysis, Inc. in the registry?
The most recently registered devices listed for Technalysis, Inc. include CELLEXIS HEMATOLOGY ANALYZER, HEMAVIEW DARKFIELD MICROSCOPE SYSTEM and TECHLYTE ELECTROLYTE ANALYZER.