DAP · Class II · 21 CFR 864.7320

FDA Product Code DAP: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Under FDA product code DAP, fibrinogen and fibrin split product antigen/antibody detection systems are cleared for the evaluation of coagulation disorders.

These tests measure fibrin degradation products and D-dimer in plasma to detect excessive fibrinolysis, disseminated intravascular coagulation, and venous thromboembolism. Elevated FDP and D-dimer indicate ongoing coagulation and fibrinolysis activity.

DAP devices are Class II medical devices, regulated under 21 CFR 864.7320 and reviewed by the FDA Hematology panel.

Leading manufacturers include Instrumentation Laboratory CO, Dade Behring, Inc. and Organon Teknika Corp..

57
Total
57
Cleared
137d
Avg days
1986
Since
57 devices
25–48 of 57
Cleared Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810
bioMerieux, Inc.
Hematology · 204d
Cleared Dec 26, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549
Sigma Diagnostics, Inc.
Hematology · 63d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948
Kamiya Biomedical Co.
Hematology · 239d
Cleared Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706
Roche Diagnostics Corp.
Hematology · 198d
Cleared Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267
Sigma Diagnostics, Inc.
Hematology · 148d
Cleared Jun 07, 2000
MDA D-DIMER
K000492
Organon Teknika Corp.
Hematology · 113d
Cleared Jan 28, 2000
ADVANCED D-DIMER
K992957
Dade Behring, Inc.
Hematology · 148d
Cleared Apr 16, 1998
MDA D-DIMER
K974776
Organon Teknika Corp.
Hematology · 115d
Cleared Mar 10, 1998
VIDAS D-DIMER (DD) ASSAY
K973819
Biomerieux Vitek, Inc.
Hematology · 154d
Cleared Nov 04, 1997
IL TEST D-DIMER
K972696
Instrumentation Laboratory CO
Hematology · 109d
Cleared Jun 26, 1997
STA-LIATEST D-DI TEST KIT
K964728
American Bioproducts Co.
Hematology · 213d
Cleared May 23, 1997
STA D-DI CALIBRATOR KIT
K964718
American Bioproducts Co.
Hematology · 179d
Cleared Sep 20, 1994
AURATEK FDP
K943787
Organon Teknika Corp.
Hematology · 48d
Cleared Aug 05, 1992
FIBRINOSTIKA TDP MICROELISA SYSTEM
K915698
Organon Teknika Corp.
Hematology · 226d
Cleared Jul 13, 1992
FDP PLASMA TEST KIT
K920943
American Bioproducts Co.
Hematology · 137d
Cleared Oct 09, 1991
FIBRINOSTIKA FBDP MICROELISA SYSTEM
K912876
Organon Teknika Corp.
Hematology · 100d
Cleared Aug 06, 1987
DATA-FI DIMERTEST LATEX ASSAY
K872195
American Dade
Hematology · 59d
Cleared Sep 16, 1986
ASSERACHROM D-DI KIT
K862156
American Bioproducts Co.
Hematology · 103d