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Radioimmunoassay, Androstenedione

FDA product code CIZ · Class 1 · Clinical Chemistry

25
Registered devices
125
Adverse events
5
Recalls
10
510(k) clearances

Devices with this code

ADVIA Centaur Androstenedione kit — Siemens Healthcare Diagnostics Inc.Androstenedione-ELISA — Diasource Immunoassays S.A. SAANDROSTENEDIONE-RIA-CT — Diasource Immunoassays S.A. SAAndrostenedione ELISA — DRG International IncANST AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.ANST AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.AccuDiag™ ANST (Androstenedione) ELISA — Diagnostic Automation, Inc.Elecsys Androstenedione — Roche Diagnostics GmbHANST AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Elecsys Androstenedione — Roche Diagnostics GmbHAndrostenedione ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungiFlash-Androstenedione — Shenzhen YHLO Biotech Co., Ltd.IMMULITE® 2000 Systems AND Androstenedione — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDANST AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Androstenedione — DRG Instruments Gesellschaft mit beschränkter HaftungAndrostenedione ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIDS Androstenedione — IMMUNODIAGNOSTIC SYSTEMS LIMITEDAndrostenedione ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAndrostenedione ELISA — EUROIMMUN Medizinische Labordiagnostika AGAndrostenedione — DRG Instruments Gesellschaft mit beschränkter HaftungAndrostenedione ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.IMMULITE®/IMMULITE® 1000 Systems AND Androstenedione — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDBC Androstenedione ELISA — Diagnostics Biochem Canada IncAtellica IM Androstenedione kit — Siemens Healthcare Diagnostics Inc.

Recent recalls

DateFirmReason
2014-06-09Siemens Healthcare Diagnostics Inc.The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
2013-12-20Siemens Healthcare DiagnosticsSiemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/I
2013-12-20Siemens Healthcare DiagnosticsSiemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/I
2004-07-15Diasorin Inc.Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
2004-05-25Diasorin Inc.Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.