Home › Device types › CZP
Iga, Antigen, Antiserum, Control
FDA product code CZP · Class 2 · Immunology
23
Registered devices
11
Adverse events
3
Recalls
54
510(k) clearances
Devices with this code
IgA — RANDOX LABORATORIES LIMITEDIgA — RANDOX LABORATORIES LIMITEDTinaquant IgA Gen2 — Roche Diagnostics GmbHARCHITECT — ABBOTT IRELANDHuman IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit — THE BINDING SITE GROUP LIMITEDPoly Rb A-Hu IgA — AGILENT TECHNOLOGIES SINGAPORE PTE LTDTinaquant IgA Gen2 — Roche Diagnostics GmbHYumizen C1200 Immunoglobulin A — HORIBA ABX SASIgA — RANDOX LABORATORIES LIMITEDAlinity — ABBOTT IRELANDN Latex IgA — Siemens Healthcare Diagnostics Products GmbHAntiserum to Human IgA (alpha chain specific) — KENT LABORATORIES INCIgA — RANDOX LABORATORIES LIMITEDImmunoglobulin A — Roche Diagnostics GmbHPoly Rb A-Hu IgA — AGILENT TECHNOLOGIES SINGAPORE PTE LTDTinaquant IgA Gen2 — Roche Diagnostics GmbHN Latex IgA — Siemens Healthcare Diagnostics Products GmbHARCHITECT — ABBOTT LABORATORIESAlinity — Abbott GmbHTina-quant IgA Gen.2 — Roche Diagnostics GmbHPoly Rb A-Hu IgA, IgG, IgM — AGILENT TECHNOLOGIES SINGAPORE PTE LTDARCHITECT — ABBOTT LABORATORIESARCHITECT — Abbott GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-01 | Randox Laboratories Ltd. | Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 |
| 2019-06-03 | Roche Diagnostics Corporation | Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 |
| 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 |
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