Brahms Diagnostica, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Brahms Diagnostica, LLC makes
Brahms Diagnostica, LLC manufactures immunoassay test kits for detecting thyroid-related antibodies and antigens, including anti-thyroglobulin (anti-TG), anti-thyroid peroxidase (anti-TPO), and thyroglobulin (TG). These tests are designed for in vitro diagnostic use, employing luminometric or chemiluminescent detection methods to measure specific biomarkers in patient samples.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These tests are intended for laboratory use in the US and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Brahms Diagnostica Lumitest Trak Human Ref K033454
510(k) 510(k)Brahms Diagnostica Dynotest Anti-Tg Ref K992790
510(k) 510(k)Brahms Diagnostica Lumitest Anti-Tg Ref K000286
510(k) 510(k)Brahms Diagnostica Dynotest Tg-Plus Ref K021057
510(k) 510(k)Brahms Diagnostica Dynotest Anti-Tpo Ref K992791
510(k) 510(k)Brahms Diagnostica Lumitest Anti-Tpo Ref K000287
510(k) 510(k)
Frequently asked questions
How many devices does Brahms Diagnostica, LLC have in the registry?
The registry currently lists 6 devices for Brahms Diagnostica, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brahms Diagnostica, LLC's devices?
Among its 6 most recently registered devices, Brahms Diagnostica, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do Brahms Diagnostica, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Brahms Diagnostica, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Brahms Diagnostica, LLC in the registry?
The most recently registered devices listed for Brahms Diagnostica, LLC include BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN, BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG, BRAHMS DIAGNOSTICA LUMITEST ANTI-TG and BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS.