Home › Device types › CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
FDA product code CDZ · Class 1 · Clinical Chemistry
113
Registered devices
163
Adverse events
19
Recalls
89
510(k) clearances
Devices with this code
Atellica IM TSTII — Siemens Healthcare Diagnostics Inc.Free Testosterone ELISA — DRG International IncIMMULITE®/IMMULITE® 1000 Systems SBG SHBG Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDPantex Universal — PantexLumipulse G Testosterone Immunoreaction Cartridges — FUJIREBIO INC.ADVIA Centaur® TST II — Siemens Healthcare Diagnostics Inc.Free Testosterone ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungElecsys Testosterone II — Roche Diagnostics GmbHFastPack® Testo Kit (50) — QUALIGEN INC.Testosterone ELISA — DRG International IncPointe Scientific, Inc. Progesterone — HORIBA INSTRUMENTS INCORPORATEDIDS-iSYS Free Testosterone — IMMUNODIAGNOSTIC SYSTEMS LIMITEDSHBG AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.MP Biomedicals LLC — Mp Biomedicals, LLCIMMULITE®/IMMULITE® 1000 Systems SBG SHBG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems SBG SHBG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® TSTO — Siemens Healthcare Diagnostics Inc.Testosterone Luminescence Immunoassay — IBL International GmbHPantex — PantexAccess Testosterone Calibrator — Beckman Coulter, Inc.Free Testosterone ELISA — EUROIMMUN Medizinische Labordiagnostika AGElecsys SHBG — Roche Diagnostics GmbHIMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDFree Testosterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-12 | Tosoh Bioscience Inc | The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could ca |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-05-05 | Beckman Coulter, Inc. | Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone |
| 2024-12-03 | Qualigen Inc | Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected |
| 2024-07-05 | DRG International, Inc. | Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results |
| 2022-10-25 | Siemens Healthcare Diagnostics, Inc. | Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Tot |
| 2019-11-06 | Qualigen Inc | The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone B |
| 2019-05-21 | DRG Instruments GmbH | Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of t |
| 2018-11-30 | Tosoh Bioscience Inc | |
| 2018-03-21 | Siemens Healthcare Diagnostics, Inc. | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elev |
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