Alpha-1-antitrypsin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5130
Recent MDR events
5 adverse event reports on file
- TINA-QUANT ¿1-ANTITRYPSIN VER.2Jul 22, 2026MalfunctionRoche Diagnostics1823260-2026-02979
- TINA-QUANT ALPHA-1 ANTITRYPSINMar 26, 2024MalfunctionRoche Diagnostics1823260-2024-00906
- AAT2 TINA-QUANT ¿1-ANTITRYPSIN VER.2Oct 3, 2019MalfunctionRoche Diagnostics1823260-2019-03553
- IMMAGE ALPHA-1-ANTITRYPSIN (AAT)Feb 7, 2012MalfunctionBeckman Coulter, Inc.2050012-2012-00339
- IMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)Nov 18, 2011MalfunctionBeckman Coulter, Inc.2050012-2011-07625
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
29 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
The Binding Site Group Ltd.
BIRMINGHAM, GB
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Beckman Coulter, Inc.
CARLSBAD, CA, US
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Beckman Coulter, Inc.
BREA, CA, US
The Binding Site
Kings Norton Birmingham, GB
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Kent Laboratories, Inc.
BELLINGHAM, WA, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Diamond Diagnostics Inc.
Budapest, HU
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Ortho Clinical Diagnostics
Singapore South West, SG
Kamiya Biomedical Company Llc
Tukwila, WA, US
510(k) clearances
30 clearances for this product code
- The Binding Site Group , Ltd.Jul 3, 2013
K123256 · HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
- Dade Behring, Inc.Jan 11, 2007
K063610 · DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- Dade Behring, Inc.Mar 28, 2006
K053072 · N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
- Ortho-Clinical Diagnostics, Inc.Dec 23, 2005
K052819 · VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
- Biokit, S.A.May 13, 2005
K050596 · QUANTIA A1-AT
- Bayer Diagnostics Corp.Sep 4, 2003
K031857 · ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
- The Binding Site, Ltd.Jul 30, 2001
K011663 · MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
- RochdiagMay 18, 2001
K010978 · TINA-QUANT ALPHA-1 ANTITRYPSIN