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Radioimmunoassay, Estriol
FDA product code CGI · Class 1 · Clinical Chemistry
19
Registered devices
16
Adverse events
2
Recalls
42
510(k) clearances
Devices with this code
uE3 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Free Estriol ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAccuDiag™ Free Estriol ELISA — Diagnostic Automation, Inc.Free Estriol ELISA — DRG International IncAutoDELFIA Unconjugated Estriol (uE3) kit — Wallac OyIMMULITE® 2000 Systems UE3 Unconjugated Estriol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDuE3 AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Free Estriol ELISA — EUROIMMUN Medizinische Labordiagnostika AGFree Estriol ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAutoDELFIA Unconjugated Estriol (uE3) kit — Wallac OyFree Estriol — DRG Instruments Gesellschaft mit beschränkter HaftungAutoDELFIA Unconjugated Estriol (uE3) kit — Wallac OyDBC Free Estriol ELISA — Diagnostics Biochem Canada IncFree Estriol — DRG International IncAutoDELFIA Unconjugated Estriol (uE3) kit — Wallac OyFree Estriol ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.uE3 AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.IMMULITE®/IMMULITE® 1000 Systems UE3 Unconjugated Estriol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDuE3 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-26 | Beckman Coulter Inc. | Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. |
| 2009-12-08 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce |
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