DEM · Class II · 21 CFR 866.5130

FDA Product Code DEM: Alpha-1-antitrypsin, Antigen, Antiserum, Control

Leading manufacturers include Ventana Medical Systems, Inc., The Binding Site, Ltd. and Dade Behring, Inc..

30
Total
30
Cleared
93d
Avg days
1976
Since

FDA 510(k) Cleared Alpha-1-antitrypsin, Antigen, Antiserum, Control Devices (Product Code DEM)

30 devices
1–24 of 30
Cleared Jul 03, 2013
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256
The Binding Site Group , Ltd.
Immunology · 258d
Cleared Jan 11, 2007
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063610
Dade Behring, Inc.
Immunology · 38d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
K053072
Dade Behring, Inc.
Immunology · 147d
Cleared Dec 23, 2005
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
K052819
Ortho-Clinical Diagnostics, Inc.
Immunology · 80d
Cleared May 13, 2005
QUANTIA A1-AT
K050596
Biokit, S.A.
Immunology · 66d
Cleared Sep 04, 2003
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
K031857
Bayer Diagnostics Corp.
Chemistry · 80d
Cleared Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
K011663
The Binding Site, Ltd.
Immunology · 62d
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AT
K993444
Kamiya Biomedical Co.
Immunology · 43d
Cleared Jan 09, 1998
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
K972640
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Oct 03, 1997
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE L26 (CD20)
K973390
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE KAPPA
K973391
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE LAMBDA
K973392
Ventana Medical Systems, Inc.
Immunology · 86d
Cleared Jul 14, 1997
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
K965100
Crestat Diagnostics, Inc.
Immunology · 206d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766
Beckman Instruments, Inc.
Immunology · 149d
Cleared Mar 30, 1994
VENTANA NEGATIVE CONTROL REAGENT
K931979
Ventana Medical Systems, Inc.
Immunology · 342d
Cleared Jul 29, 1992
IL TEST ALPHA-1-ANTITRYPSIN (AAT)
K920005
Instrumentation Laboratory CO
Immunology · 209d
Cleared Dec 09, 1991
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT
K913666
The Binding Site, Ltd.
Immunology · 112d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
K890415
Atlantic Antibodies
Immunology · 24d
Cleared Jul 08, 1988
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
K882446
Technicon Instruments Corp.
Immunology · 24d
Cleared Feb 10, 1988
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
K875281
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Feb 10, 1988
QM2/QM300 CONTROL B PACK
K875283
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 48d
Cleared Sep 16, 1980
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
K801669
J.T. Baker Chemical Co.
Immunology · 56d
Cleared Aug 21, 1978
RID SYSTEM-(ACP) TEST
K781408
Icl Scientific
Immunology · 7d

About Product Code DEM - Regulatory Context