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Alpha-1-Antitrypsin, Antigen, Antiserum, Control

FDA product code DEM · Class 2 · Immunology

26
Registered devices
4
Adverse events
1
Recalls
30
510(k) clearances

Devices with this code

K-ASSAY® Alpha-1 AT Reagent — KAMIYA BIOMEDICAL COMPANY, LLCHuman alpha 1 antitrypsin Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDAU — BECKMAN COULTER IRELAND INC.Tina-quant a1-Antitrypsin ver.2 — Roche Diagnostics GmbHCLC720 Chemistry Analyzer w/ISE — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESADVIA® Chemistry AAT Alpha-1-Antitrypsin Reagents — Siemens Healthcare Diagnostics Inc.N Antiserum to Human a1-Antitrypsin — Siemens Healthcare Diagnostics Products GmbHN Antiserum to Human a1-Antitrypsin — Siemens Healthcare Diagnostics Products GmbHARCHITECT — ABBOTT LABORATORIESAlbumin BCP — Roche Diagnostics GmbHTinaquant 1Antitrypsin ver2 — Roche Diagnostics GmbHTinaquant 1Antitrypsin ver2 — Roche Diagnostics GmbHAlinity — ABBOTT LABORATORIESTina-quant alpha1-Antitrypsin — Roche Diagnostics GmbHDimension Vista®a1-Antitrypsin Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.ARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESAtellica CH AAT — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESOptilite Alpha-1-antitrypsin Kit — THE BINDING SITE GROUP LIMITEDHuman Alpha 1 Antitrypsin NL BINDARID™ Kit — THE BINDING SITE GROUP LIMITEDARCHITECT — ABBOTT LABORATORIES

Recent recalls

DateFirmReason
2017-08-23The Binding Site Group, Ltd.The high control for the kit is recovering low and may be out of range for assigned values.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.