Home › Device types › DEW
Igg, Antigen, Antiserum, Control
FDA product code DEW · Class 2 · Immunology
37
Registered devices
74
Adverse events
4
Recalls
76
510(k) clearances
Devices with this code
Human IgG2 Subclass Single Dilution BINDARID™ Kits — THE BINDING SITE GROUP LIMITEDIgG — RANDOX LABORATORIES LIMITEDAlinity — Abbott GmbHSynchron — Beckman Coulter, Inc.ARCHITECT — Abbott GmbHIgG — RANDOX LABORATORIES LIMITEDTinaquant IgG Gen2 — Roche Diagnostics GmbHIgG — RANDOX LABORATORIES LIMITEDPoly Rb A-Hu IgG — AGILENT TECHNOLOGIES SINGAPORE PTE LTDTinaquant IgG Gen2 — Roche Diagnostics GmbHHuman IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID Kit — THE BINDING SITE GROUP LIMITEDN Cuvette Segments for BN II — Siemens Healthcare Diagnostics Products GmbHHuman IgG1 Subclass Single Dilution BINDARID™ Kits — THE BINDING SITE GROUP LIMITEDVIDAS® — BIOMERIEUX SAK-ASSAY® IgG Reagent — KAMIYA BIOMEDICAL COMPANY, LLCVIDAS® — BIOMERIEUX SAAntiserum to Human IgG (gamma chain specific) — KENT LABORATORIES INCYumizen C1200 Immunoglobulin G — HORIBA ABX SASBN II System — Siemens Healthcare Diagnostics Products GmbHARCHITECT — ABBOTT LABORATORIESMERIFLUOR GullSORB — MERIDIAN BIOSCIENCE, INC.Poly Rb A-Hu IgA, IgG, IgM — AGILENT TECHNOLOGIES SINGAPORE PTE LTDIgG — RANDOX LABORATORIES LIMITEDHuman IgG Subclass Single Dilution BINDARID™ Kit - Bulk Kit — THE BINDING SITE GROUP LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-31 | Beckman Coulter Inc. | Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the variou |
| 2010-06-28 | Beckman Coulter Inc. | The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using |
| 2003-06-06 | Beckman Coulter Inc | low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66. |
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