Elite Technology, Inc.
CanadaFDA applicant, unverified
- Devices
- 5
What Elite Technology, Inc. makes
Elite Technology, Inc. manufactures in vitro diagnostic (IVD) test kits for clinical laboratory use, including cholesterol, uric acid, gamma glutamyl transferase (GGT), urine/CSF protein, and triglycerides assays. These products are designed for quantitative or qualitative analysis of blood, urine, and cerebrospinal fluid samples in medical settings.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These test kits are intended for use in the United States and comply with relevant FDA requirements for in vitro diagnostics.
Catalogue
Cholesterol Test Kit Ref K895951
Regimes: 510(k) Registry: 510(k)Uric Acid Test Kit Ref K901001
Regimes: 510(k) Registry: 510(k)Elitech Gamma Gt Test Kit Ref K901090
Regimes: 510(k) Registry: 510(k)Protein Test For Urine And Csf Ref K900733
Regimes: 510(k) Registry: 510(k)Triglycerides Test Kit Ref K895952
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Elite Technology, Inc. have in the registry?
The registry currently lists 5 devices for Elite Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elite Technology, Inc.'s devices?
Among its 5 most recently registered devices, Elite Technology, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Elite Technology, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Elite Technology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elite Technology, Inc. in the registry?
The most recently registered devices listed for Elite Technology, Inc. include CHOLESTEROL TEST KIT, URIC ACID TEST KIT, ELITECH GAMMA GT TEST KIT and PROTEIN TEST FOR URINE AND CSF.