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Alpha-1-Antitrypsin, Antigen, Antiserum, Control
FDA product code DEM · Class 2 · Immunology
26
Registered devices
5
Adverse events
1
Recalls
30
510(k) clearances
Devices with this code
Tinaquant 1Antitrypsin ver2 — Roche Diagnostics GmbHHuman Alpha 1 Antitrypsin NL BINDARID™ Kit — THE BINDING SITE GROUP LIMITEDN Antiserum to Human a1-Antitrypsin — Siemens Healthcare Diagnostics Products GmbHN Antiserum to Human a1-Antitrypsin — Siemens Healthcare Diagnostics Products GmbHAlbumin BCP — Roche Diagnostics GmbHADVIA® Chemistry AAT Alpha-1-Antitrypsin Reagents — Siemens Healthcare Diagnostics Inc.Alinity — ABBOTT LABORATORIESAntiserum to Alpha 1 Antitrypsin — KENT LABORATORIES INCK-ASSAY® Alpha-1 AT Reagent — KAMIYA BIOMEDICAL COMPANY, LLCTinaquant 1Antitrypsin ver2 — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESTina-quant alpha1-Antitrypsin — Roche Diagnostics GmbHVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.AU — BECKMAN COULTER IRELAND INC.Dimension Vista®a1-Antitrypsin Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESTina-quant a1-Antitrypsin ver.2 — Roche Diagnostics GmbHHuman alpha 1 antitrypsin Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDOptilite Alpha-1-antitrypsin Kit — THE BINDING SITE GROUP LIMITEDAtellica CH AAT — Siemens Healthcare Diagnostics Inc.IMMAGE — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-08-23 | The 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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