Thermo Dma, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Thermo Dma, Inc. makes
Thermo DMA, Inc. manufactures laboratory reagents and calibrators for biochemical assays, including ammonia standards, fructosamine assay kits, and alkaline phosphatase reference materials. These products are designed for clinical and research settings to support accurate measurement of specific biomarkers in patient samples.
The company’s portfolio is regulated as Class II medical devices in the U.S., with individual products authorised through FDA 510(k) clearance. These devices are listed under the FDA’s regulatory framework and are intended for use in diagnostic testing environments.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Thermo Dma Data-Cal Calibrator, Model 1905-050 Ref K022108
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Thermo Dma, Inc. have in the registry?
The registry currently lists 4 devices for Thermo Dma, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Thermo Dma, Inc.'s devices?
Among its 4 most recently registered devices, Thermo Dma, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Thermo Dma, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Thermo Dma, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Thermo Dma, Inc. in the registry?
The most recently registered devices listed for Thermo Dma, Inc. include THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609, THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235, THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 and TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113.