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Radioimmunoassay, Human Growth Hormone
FDA product code CFL · Class 1 · Clinical Chemistry
52
Registered devices
81
Adverse events
5
Recalls
36
510(k) clearances
Devices with this code
hGH AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.TGF-Beta 1 ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungHGH-US — CISBIO BIOASSAYSIMMULITE® Systems IG1 CONTROL IGF-1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDhGH-IRMA — Diasource Immunoassays S.A. SAST AIA-PACK HGH — TOSOH CORPORATIONhGH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.AIA-PACK HGH Sample Diluting Solution — TOSOH CORPORATIONTGF-B2 ELISA — DRG International IncIGF-1 600 ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMULITE® 2000 Systems IG1 IGF-I Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE/IMMULITE 1000 Systems Growth Hormone — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDHuman Growth Hormone (HGH) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungElecsys hGH — Roche Diagnostics GmbHTGF-B1 ELISA — DRG International InchGH ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTGF-Beta 2 ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAIA-PACK HGH Calibrator Set — TOSOH CORPORATIONIDS-iSYS Human Growth Hormone (hGH) — IMMUNODIAGNOSTIC SYSTEMS LIMITEDTGF Beta-1 ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.hGH AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.IMMULITE®/IMMULITE® 1000 Systems GH Growth Hormone Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®/IMMULITE® 1000 Systems IGF-I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®/IMMULITE® 1000 Systems BP3 IGFBP-3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2016-04-15 | Siemens Healthcare Diagnostics, Inc. | 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment s |
| 2011-03-30 | Beckman Coulter Inc. | The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions fo |
| 2010-08-09 | Beckman Coulter Inc. | The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above |
| 2005-05-02 | Nichols Institute Diagnostics | Under recovery of diluted samples by as much as 20%. |
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