Dexall Biomedical Labs, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Dexall Biomedical Labs, Inc. makes
Dexall Biomedical Labs, Inc. manufactures enzyme immunoassay kits for detecting immunoglobulin E (IgE) antibodies, including diagnostic tests for allergens and food-specific allergens. These products are designed for in vitro use in clinical laboratories to identify allergic sensitivities.
The company’s portfolio consists of Class II medical devices, authorised via the FDA’s 510(k) pathway. These products are listed under regulatory registries for in vitro diagnostic (IVD) devices in the United States.
Catalogue
Allerg-E Ige Enzyme Immunoassay Kit Ref K853607
Regimes: 510(k) Registry: 510(k)Additional Allergens For Allerg*ens Eia Kit Ref K875066
Regimes: 510(k) Registry: 510(k)Allerg*ens Enzyme Immunoassay Kit Ref K864696
Regimes: 510(k) Registry: 510(k)Addit. Allergens To Include Foods For Allerg*ens Ref K885269
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dexall Biomedical Labs, Inc. have in the registry?
The registry currently lists 4 devices for Dexall Biomedical Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dexall Biomedical Labs, Inc.'s devices?
Among its 4 most recently registered devices, Dexall Biomedical Labs, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Dexall Biomedical Labs, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Dexall Biomedical Labs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dexall Biomedical Labs, Inc. in the registry?
The most recently registered devices listed for Dexall Biomedical Labs, Inc. include ALLERG-E IGE ENZYME IMMUNOASSAY KIT, ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT, ALLERG*ENS ENZYME IMMUNOASSAY KIT and ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS.