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Radioimmunoassay, Follicle-Stimulating Hormone
FDA product code CGJ · Class 1 · Clinical Chemistry
61
Registered devices
32
Adverse events
9
Recalls
88
510(k) clearances
Devices with this code
Access hFSH — Beckman Coulter, Inc.ADVIA Centaur® FSH MCM — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® FSH — Siemens Healthcare Diagnostics Inc.DELFIA hFSH kit — Wallac OyAIA-PACK FSH Calibrator Set — TOSOH CORPORATIONDBC Follicle Stimulating Hormone (FSH) ELISA — Diagnostics Biochem Canada IncFSH ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMULITE® 2000 Systems FSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDINSTANT-VIEW FSH Cassette Test — ALFA SCIENTIFIC DESIGNS, INC.Elecsys FSH — Roche Diagnostics GmbHMonobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 960 Wells — MONOBIND, INC.Alinity — ABBOTT IRELANDFSH — DRG Instruments Gesellschaft mit beschränkter HaftungVITROS — ORTHO CLINICAL DIAGNOSTICSFSH ELISA — DRG International IncIMMULITE® 2000 Systems FSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMonobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 480 Wells — MONOBIND, INC.IMMULITE 2000 FSH Kit Domestic 600T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCL AIA-PACK FSH TEST CUP — TOSOH CORPORATIONAIA-PACK FSH Sample Diluting Solution — TOSOH CORPORATIONOne Step Menopausal Test — UNIVERSAL MEDITECH INC.Access hFSH Calibrators — Beckman Coulter, Inc.FSH AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Monobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 192 Wells — MONOBIND, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2022-03-25 | Ortho-Clinical Diagnostics, Inc | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecis |
| 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 |
| 2018-07-12 | Ortho Clinical Diagnostics Inc | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are |
| 2018-04-09 | BioMerieux SA | Invalid calibration with low calibrator S1 while using the product. |
| 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 |
| 2016-11-16 | PerkinElmer Health Sciences, Inc. | A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% fo |
| 2012-11-05 | Applied Medical Resources Corp | Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the |
| 2012-08-07 | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 |
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