Aesku, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Aesku, Inc. makes
Aesku, Inc. manufactures a range of diagnostic test kits, including ELISA-based assays for the detection of antinuclear antibodies, anti-tissue transglutaminase, anti-cardiolipin, and anti-Saccharomyces cerevisiae antibodies. These products are designed for the identification of specific biomarkers associated with autoimmune and gastrointestinal conditions.
The company is based in the United States, and its portfolio of Class II medical devices is listed in the FDA 510(k) regulatory registry.
Catalogue
Aeskulisa Ana 8PRO Ref K032469
Regimes: 510(k) Registry: 510(k)Aeskulska BETA2-Glyco-A Ref K062217
Regimes: 510(k) Registry: 510(k)Aeskulisa Ana Hep-2 Ref K040953
Regimes: 510(k) Registry: 510(k)Aeskulisa Asca A Ref K051492
Regimes: 510(k) Registry: 510(k)Aeskulisa Cardiolipin Agm Ref K040463
Regimes: 510(k) Registry: 510(k)Aeskulisa Ttg A And Aeskulisa Ttg G Ref K042644
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aesku, Inc. have in the registry?
The registry currently lists 6 devices for Aesku, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aesku, Inc.'s devices?
Among its 6 most recently registered devices, Aesku, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Aesku, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Aesku, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aesku, Inc. in the registry?
The most recently registered devices listed for Aesku, Inc. include AESKULISA ANA 8PRO, AESKULSKA BETA2-GLYCO-A, AESKULISA ANA HEP-2 and AESKULISA ASCA A.