Home › Device types › JKD
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
C-PEP II-RIA-CT — Diasource Immunoassays S.A. SAC-Peptide ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungALPCO C-peptide ELISA Jumbo — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ARCHITECT — ABBOTT LABORATORIESAtellica IM CpS — Siemens Healthcare Diagnostics Inc.AIA-PACK C-Peptide II Sample Diluting Solution — TOSOH CORPORATIONProinsulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungSTELLUX® Chemi Human Total Proinsulin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.C-Peptide & Insulin Diabetes Panel AccuLite VAST CLIA Test System - 192 Wells — MONOBIND, INC.IMMULITE® 2000 Systems C-Peptide — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMercodia C-peptide ELISA — Mercodia ABAtellica IM CpS — Siemens Healthcare Diagnostics Inc.C-Peptide AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.ALPCO C-peptide ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Elecsys C-Peptide — Roche Diagnostics GmbHAIA-PACK C-Peptide Control Set — TOSOH CORPORATIONIMMULITE® Systems CPE CONTROL C-Peptide — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMonobind AccuBind C-Peptide & Insulin VAST ELISA Kit - 192 Wells — MONOBIND, INC.C-Peptide & Insulin Diabetes Panel AccuBind VAST ELISA Test System - 96 Wells — MONOBIND, INC.C-Peptide AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Proinsulin ELISA — DRG International IncElecsys C-Peptide — Roche Diagnostics GmbHC-PEP-EASIA — Diasource Immunoassays S.A. SAiFlash-C-Peptide — Shenzhen YHLO Biotech Co., Ltd.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.