Alpha-1-lipoprotein, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5580
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Abbott Laboratories Diagnostic DivTerminatedJan 11, 2006
Clinical Chemistry Apolipoprotein A1, List Number 9D92-20
These specific protein assays are not meeting the 57-day on board stability claim
Z-0383-06 · View FDA record ↗ - Abbott Laboratories, IncTerminatedUnknown
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of
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 various products.
Z-1991-2019 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Abbott Gmbh
Wiesbaden Hesse, DE
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Kamiya Biomedical Company Llc
Tukwila, WA, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Abbott Laboratories
Lake Forest, IL, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Diamond Diagnostics Inc.
Budapest, HU
Abbott Laboratories
Irving, TX, US
Fisher Diagnostics
MIDDLETOWN, VA, US
Abbott Ireland Diagnostics Division
Longford, IE
510(k) clearances
17 clearances for this product code
- Roche Diagnostics Corp.Nov 16, 2001
K013249 · TINA-QUANT APOLIPOPROTEIN VER.2
- Bayer Corp.May 18, 2000
K000921 · BAYER ADVIA IMS SYSTEM; 200 + 3
- Kamiya Biomedical Co.Oct 28, 1999
K993354 · K-ASSAY APO B
- Kamiya Biomedical Co.Oct 25, 1999
K993345 · K-ASSAY APO AI
- Roche Diagnostics Corp.Apr 14, 1999
K990594 · INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
- Abbott LaboratoriesJan 29, 1999
K983289 · APOLIPOPROTEIN A1
- Crestat Diagnostics, Inc.Aug 1, 1997
K964294 · N-ASSAY TIA APO A1/B MULTI CALIBRATOR
- Crestat Diagnostics, Inc.Aug 1, 1997
K964296 · N-ASSAY TIA APO B TEST KIT