Home › Device types › GGT
Assay, Erythropoietin
FDA product code GGT · Class 2 · Hematology
11
Registered devices
3
Adverse events
5
Recalls
20
510(k) clearances
Devices with this code
Access EPO — Beckman Coulter, Inc.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.ADVIA Centaur EPO — Siemens Healthcare Diagnostics Inc.EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Atellica IM EPO — Siemens Healthcare Diagnostics Inc.EPO (Erythropoietin) ELISA — DRG International IncEPO (Erythropoietin) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungErythropoietin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-03 | Beckman Coulter, Inc. | Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the aff |
| 2024-01-24 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC |
| 2024-01-24 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC |
| 2022-06-14 | R & D Systems, Inc. | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE ma |
| 2005-09-30 | Nichols Institute Diagnostics | Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabel |
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