FDA Product Code DER: Alpha-1-lipoprotein, Antigen, Antiserum, Control
Leading manufacturers include Photec Diagnostics, Inc., Crestat Diagnostics, Inc. and Kamiya Biomedical Co..
17
Total
17
Cleared
93d
Avg days
1981
Since
FDA 510(k) Cleared Alpha-1-lipoprotein, Antigen, Antiserum, Control Devices (Product Code DER)
17 devices
Cleared
Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
Roche Diagnostics Corp.
Chemistry
49d
Cleared
May 18, 2000
BAYER ADVIA IMS SYSTEM
Bayer Corp.
Chemistry
57d
Cleared
Oct 28, 1999
K-ASSAY APO B
Kamiya Biomedical Co.
Chemistry
23d
Cleared
Oct 25, 1999
K-ASSAY APO AI
Kamiya Biomedical Co.
Chemistry
20d
Cleared
Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
Roche Diagnostics Corp.
Chemistry
49d
Cleared
Jan 29, 1999
APOLIPOPROTEIN A1
Abbott Laboratories
Immunology
133d
Cleared
Aug 01, 1997
N-ASSAY TIA APO A1 TEST KIT
Crestat Diagnostics, Inc.
Immunology
276d
Cleared
Aug 01, 1997
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
Crestat Diagnostics, Inc.
Immunology
276d
Cleared
Aug 01, 1997
N-ASSAY TIA APO B TEST KIT
Crestat Diagnostics, Inc.
Immunology
276d
Cleared
May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
Roche Diagnostic Systems, Inc.
Immunology
90d
Cleared
Sep 24, 1990
UC IMU A
Eucardio Laboratory, Inc.
Immunology
18d
Cleared
Jun 18, 1987
QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
Solomon Park Research Laboratories
Immunology
20d
Cleared
Jan 24, 1986
APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1
Photec Diagnostics, Inc.
Immunology
51d
Cleared
Aug 28, 1985
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
Photec Diagnostics, Inc.
Immunology
40d
Cleared
Jun 05, 1985
APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
Photec Diagnostics, Inc.
Immunology
44d
Cleared
May 21, 1984
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
Ventrex Laboratories, Inc.
Immunology
87d
Cleared
Jan 05, 1981
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
Hyland Therapeutic Div., Travenol Laboratories
Immunology
76d