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ACTH [Adrenocorticotropic Hormone] ELISA
BIOMERICA, INC. · Model 7023 · UDI-DI 08305900070231
1
510(k) clearances
33
Adverse events
6
Recalls
20
Facilities
Description
The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2018-11-30 | Tosoh Bioscience Inc | |
| 2011-12-13 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, expo |
| 2005-04-22 | Nichols Institute Diagnostics | Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.