Home › Device types › CGF
Radioimmunoassay, Estrone
FDA product code CGF · Class 1 · Clinical Chemistry
16
Registered devices
0
Adverse events
4
Recalls
4
510(k) clearances
Devices with this code
Estrone-RIA-CT — Diasource Immunoassays S.A. SADBC Estrone ELISA — Diagnostics Biochem Canada IncEstrone ELISA — EUROIMMUN Medizinische Labordiagnostika AGEstrone ELISA — DRG International IncDBC Estrone ELISA — Diagnostics Biochem Canada IncEstrone ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungEstrone ELISA — Diasource Immunoassays S.A. SAEstrone-sulfate RIA — IMMUNOTECH s.r.o.Estrone ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungEstrone ELISA — IBL AmericaEstrone ELISA — DRG International IncEstrone ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungEstrone RIA — IMMUNOTECH s.r.o.Estrone Serum ELISA — DRG International IncEstrone Serum — DRG Instruments Gesellschaft mit beschränkter HaftungEstrone ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-15 | Immunotech A.S. | The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare |
| 2025-06-12 | Immunotech A.S. | Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient re |
| 2025-06-12 | Beckman Coulter Inc. | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity |
| 2010-04-22 | Beckman Coulter Inc. | Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 9926 |
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