Aerscher, Inc.
Country not established
- Devices
- 3
What Aerscher, Inc. makes
Aerscher, Inc. manufactures in vitro diagnostic (IVD) devices for detecting occult blood in biological fluids, including faecal occult blood tests. Their products include rapid colorimetric kits and reagent-based tests designed for clinical use, such as the HemaPrompt FG, HemaPrompt, and FHT (Fecal Heme Test). These tests are intended for screening purposes in healthcare settings.
The company’s portfolio is regulated under Class II medical devices in the US, with devices authorised through FDA pathways including 510(k) clearances and the Unique Device Identifier (UDI) system. Their products are listed under these regulatory frameworks, ensuring compliance with US medical device regulations.
Catalogue
- Registry: GUDID
- Registry: GUDID
Fht (Fecal Heme Test) Ref K905782
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 926911454
- [email protected]
- Phone
- 410-778-2957
Frequently asked questions
How many devices does Aerscher, Inc. have in the registry?
The registry currently lists 3 devices for Aerscher, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aerscher, Inc.'s devices?
Among its 3 most recently registered devices, Aerscher, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Aerscher, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Aerscher, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aerscher, Inc. in the registry?
The most recently registered devices listed for Aerscher, Inc. include HemaPrompt FG HPFG, HemaPrompt HP and FHT (FECAL HEME TEST).