Alerchek, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Alerchek, Inc. makes
Alerchek, Inc. manufactures lateral flow immunoassay devices, including the FLIPSCREEN QAT for qualitative allergen testing and the FLIPSCREEN Total E and Specific E assays for measuring immunoglobulin E levels in serum or plasma. These products are designed for point-of-care or laboratory use to detect and quantify specific allergens or immune responses.
The company’s portfolio consists of Class II medical devices, each authorised through the FDA’s 510(k) clearance process. These devices are listed under the US regulatory framework and are intended for commercial distribution within the United States.
Catalogue
Flipscreen Qat Ref K874802
Regimes: 510(k) Registry: 510(k)Flipscreen (Tm) Total E Immunoassay Ref K885307
Regimes: 510(k) Registry: 510(k)Flipscreen Specific E (Pe, Se, Ne, Sw, Nw) Assay Ref K860027
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alerchek, Inc. have in the registry?
The registry currently lists 3 devices for Alerchek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alerchek, Inc.'s devices?
Among its 3 most recently registered devices, Alerchek, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Alerchek, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Alerchek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alerchek, Inc. in the registry?
The most recently registered devices listed for Alerchek, Inc. include FLIPSCREEN QAT, FLIPSCREEN (TM) TOTAL E IMMUNOASSAY and FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY.