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Radioimmunoassay, C-Peptides Of Proinsulin
FDA product code JKD · Class 1 · Clinical Chemistry
42
Registered devices
19
Adverse events
5
Recalls
10
510(k) clearances
Devices with this code
STELLUX® Chemi Human C-peptide ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Monobind AccuBind C-Peptide ELISA Kit - 192 Wells — MONOBIND, INC.Mercodia C-peptide ELISA — Mercodia ABALPCO C-peptide ELISA Jumbo — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.C-Peptide & Insulin Diabetes Panel AccuBind VAST ELISA Test System - 96 Wells — MONOBIND, INC.ADVIA Centaur® CpS — Siemens Healthcare Diagnostics Inc.C-PEP-EASIA — Diasource Immunoassays S.A. SAAccess C-Peptide — Beckman Coulter, Inc.C-Peptide & Insulin Diabetes Panel AccuLite VAST CLIA Test System - 192 Wells — MONOBIND, INC.ARCHITECT — Abbott GmbHElecsys C-Peptide — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESVITROS — ORTHO CLINICAL DIAGNOSTICSIMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMercodia Ultrasensitive C-peptide ELISA — Mercodia ABProinsulin ELISA — DRG International IncIMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDProinsulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMULITE® 2000 Systems PEP C-Peptide Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAtellica IM CpS MCM — Siemens Healthcare Diagnostics Inc.Elecsys C-Peptide — Roche Diagnostics GmbHIMMULITE® 2000 Systems C-Peptide — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDC-Peptide AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.AccuDiag™ C-Peptide ELISA Kit — Diagnostic Automation, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-21 | DRG International, Inc. | ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible |
| 2020-04-01 | Abbott Laboratories | Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a |
| 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 |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2011-07-11 | Abbott Laboratories | C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls. |
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