Home › Device types › DER
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
FDA product code DER · Class 2 · Immunology
18
Registered devices
3
Adverse events
2
Recalls
17
510(k) clearances
Devices with this code
ARCHITECT — ABBOTT IRELANDTinaquant Apolipoprotein A1 ver2 — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® APO B REAGENT CC633 — CAROLINA LIQUID CHEMISTRIES CORPORATIONTinaquant Apolipoprotein A1 ver2 — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAlinity — Abbott GmbHAI ver2 Tinaquant Apolipoprotein AI ver2 — Roche Diagnostics GmbHAlinity — ABBOTT IRELANDK-ASSAY® Apo B Reagent — KAMIYA BIOMEDICAL COMPANY, LLCARCHITECT — ABBOTT LABORATORIESCAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633 — CAROLINA LIQUID CHEMISTRIES CORPORATIONTina-quant Apolipoprotein A-1 ver.2 — Roche Diagnostics GmbHTinaquant Apolipoprotein AI ver2 — Roche Diagnostics GmbHARCHITECT — Abbott GmbHK-ASSAY® Apo AI Reagent — KAMIYA BIOMEDICAL COMPANY, LLCK-ASSAY® Apo B Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2005-11-10 | Abbott Laboratories Diagnostic Div | These specific protein assays are not meeting the 57-day on board stability claim |
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