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Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
FDA product code JKC · Class 1 · Clinical Chemistry
57
Registered devices
24
Adverse events
7
Recalls
28
510(k) clearances
Devices with this code
DBC Dehydroepiandrosterone (DHEA) ELISA — Diagnostics Biochem Canada IncDHEA — DRG International IncAtellica IM DHEAS — Siemens Healthcare Diagnostics Inc.DHEA-S — DRG Instruments Gesellschaft mit beschränkter HaftungDHEA-S ELISA — DRG International IncST AIA-PACK DHEA-S Sample Diluting Solution — TOSOH CORPORATIONAtellica IM DHEAS2 100T KIT — Siemens Healthcare Diagnostics Inc.Ionify Steroids 2 — Roche Diagnostics GmbHDHEA AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.DHEA ELISA — DRG International IncIMMULITE® 2000 Systems DHS DHEA-SO4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHEA-S — DRG Instruments Gesellschaft mit beschränkter HaftungAtellica IM DHEAS — Siemens Healthcare Diagnostics Inc.DHEA-ELISA — Diasource Immunoassays S.A. SAST AIA-PACK DHEA-S — TOSOH CORPORATIONDHEA-S ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungDHEA-S-RIA-CT — Diasource Immunoassays S.A. SADHEA-S AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Access DHEA-S — Beckman Coulter, Inc.Dehydroepiandrosterone (DHEA) ELISA — EUROIMMUN Medizinische Labordiagnostika AGDHEA — DRG Instruments Gesellschaft mit beschränkter HaftungARCHITECT — Abbott GmbHAtellica IM DHEAS — Siemens Healthcare Diagnostics Inc.IMMULITE®/IMMULITE® 1000 Systems DHS DHEASO4 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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. |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimensio |
| 2017-12-14 | Abbott Gmbh & Co. KG | Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old. |
| 2012-11-14 | Siemens Healthcare Diagnostics, Inc | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on t |
| 2010-09-09 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may ov |
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