Home › Device types › CHP
Radioimmunoassay, Estradiol
FDA product code CHP · Class 1 · Clinical Chemistry
88
Registered devices
727
Adverse events
31
Recalls
50
510(k) clearances
Devices with this code
Ultra-sensitive Estradiol RIA — IMMUNOTECH s.r.o.MP Biomedicals LLC — Mp Biomedicals, LLCADVIA Centaur® eE2 — Siemens Healthcare Diagnostics Inc.Ionify Steroids 1 — Roche Diagnostics GmbHiFlash-E2 — Shenzhen YHLO Biotech Co., Ltd.Pantex — Pantex17beta-Estradiol Saliva Luminescence Immunoassay — IBL International GmbHPantex — PantexSalivary Estradiol ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungLumipulse G E2-III Immunoreaction Cartridges — FUJIREBIO INC.Estradiol — DRG International IncEstradiol ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ST AIA-PACK hsE2 SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONSalivary Progesterone HS ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungARCHITECT — ABBOTT IRELANDCL AIA-PACK hs-E2 TEST CUP — TOSOH CORPORATIONEstradiol — DRG Instruments Gesellschaft mit beschränkter HaftungE2 RIA CT — Diasource Immunoassays S.A. SAEstradiol (serum) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungE2 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Estradiol Sensitive ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungUltrasensitive Estradiol ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ST AIA-PACK E2 — TOSOH CORPORATIONVITROS — ORTHO CLINICAL DIAGNOSTICS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2022-03-03 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2020-02-05 | Siemens Healthcare Diagnostics, Inc. | Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinte |
| 2020-02-05 | Siemens Healthcare Diagnostics, Inc. | Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinte |
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