Home › Device types › CKG
Radioimmunoassay, Acth
FDA product code CKG · Class 2 · Clinical Chemistry
19
Registered devices
33
Adverse events
6
Recalls
30
510(k) clearances
Devices with this code
ACTH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.IDS ACTH II — IMMUNODIAGNOSTIC SYSTEMS LIMITEDACTH (Adrenocorticotropic Hormone) ELISA — DRG International IncACTH [Adrenocorticotropic Hormone] ELISA — BIOMERICA, INC.ST AIA-PACK ACTH — TOSOH CORPORATIONIMMULITE®/IMMULITE® 1000 Systems ACT ACTH Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDACTH (Adrenocorticotropic Hormone) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungACTH AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Elecsys ACTH — Roche Diagnostics GmbHACTH [Adrenocorticotropic Hormone] ELISA — BIOMERICA, INC.ImmuChem hACTH Double Antibody 125I RIA Kit — MP BIOMEDICALS, LLCACTH AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.ImmuChem hACTH Double Antibody 125I RIA Kit — MP BIOMEDICALS, LLCIMMULITE® 2000 Systems ACT ACTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAdrenocorticotropic Hormone ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.AIA-PACK ACTH Sample Diluting Solution — TOSOH CORPORATIONScantibodies Laboratory, Inc. — SCANTIBODIES LABORATORY, INC.IMMULITE®/IMMULITE® 1000 Systems ACT ACTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys ACTH Test System — Roche Diagnostics GmbH
Recent 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 miss |
| 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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