Gds Technology, LLC
United StatesFDA applicant, unverified
- Devices
- 8
What Gds Technology, LLC makes
Gds Technology, LLC produces point-of-care diagnostic test systems for blood chemistry analysis, including glucose, hemoglobin, ketones, cholesterol, salicylate, and acetaminophen monitoring. Their products are designed for rapid, enzymatic-based measurements in clinical and home settings, supporting real-time patient assessment.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several authorised via the 510(k) clearance pathway. These products are listed in the FDA’s regulatory database and are manufactured in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Glucosite Test System Ref K971145
Regimes: 510(k) Registry: 510(k)Hemosite Test System Ref K994073
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Hemosite Test System Ref K973649
Regimes: 510(k) Registry: 510(k)Cholesite Test System Ref K992132
Regimes: 510(k) Registry: 510(k)Gds Enzymatic Salicylate Reagent Ref K882038
Regimes: 510(k) Registry: 510(k)Gds Enzymatic Acetaminophen Reagent Ref K880829
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gds Technology, LLC have in the registry?
The registry currently lists 8 devices for Gds Technology, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gds Technology, LLC's devices?
Among its 8 most recently registered devices, Gds Technology, LLC has devices listed in FDA 510(k) (8 devices).
What risk classes do Gds Technology, LLC's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Gds Technology, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gds Technology, LLC in the registry?
The most recently registered devices listed for Gds Technology, LLC include STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090, GLUCOSITE TEST SYSTEM, HEMOSITE TEST SYSTEM and KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON.