Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
FDA product code DAP · 56 cleared devices
Class 2
Hematology
- Regulation
- 21 CFR 864.7320
- Review panel
- HE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1986-09-16 – 2026-08-11
DAP
2026-08-11
DAP
2017-11-22
HemosIL D-Dimer HS 500
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DAP
2016-12-10
STA® - Liatest® D-Di
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DAP
2016-10-27
HemosIL D-Dimer HS
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DAP
2012-07-31
VIDAS D-DIMER EXCLUSION II (DEX2)
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DAP
2011-05-16
STRATUS CS ACUTE CARE D-DIMER
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DAP
2010-11-29
INNOVANCE D-DIMER, MODEL OPBP09
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DAP
2010-02-05
HEMOSIL D-DIMER HS 500, CONTROLS
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DAP
2009-10-29
INNOVANCE D-DIMER, MODEL OPBP09
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DAP
2008-10-24
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
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DAP
2008-07-31
HEMOSIL D-DIMER
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DAP
2008-02-13
DIMERTEST
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DAP
2007-09-17
HEMOSIL D-DIMER HS
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DAP
2007-03-23
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
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DAP
2005-08-17
STRATUS CS D-DIMER
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DAP
2005-04-26
HEMOSIL D-DIMER HS
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DAP
2005-03-10
HEMOSIL D-DIMER
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DAP
2004-12-07
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
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DAP
2004-09-01
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
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DAP
2004-08-11
ADVANCED D-DIMER ASSAY
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DAP
2004-06-25
TRIAGE PROFILER S.O.B. PANEL
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DAP
2004-06-10
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
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DAP
2003-10-24
QUANTEX D-DIMER
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DAP
2003-09-02
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
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DAP
2003-06-27
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
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DAP
2003-01-16
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
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DAP
2002-11-27
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
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DAP
2002-10-03
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
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DAP
2002-03-15
AUTODIMER ASSAY MODEL # 1431
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DAP
2001-12-26
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
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DAP
2001-11-15
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
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DAP
2001-11-15
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
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DAP
2001-05-18
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
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DAP
2001-03-16
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
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DAP
2001-03-15
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
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DAP
2001-02-05
MINIQUANT D-DIMER, MODEL 1447
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DAP
2000-06-07
MDA D-DIMER
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DAP
2000-01-28
ADVANCED D-DIMER
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DAP
1998-05-26
DIMERTEST LATEX ASSAY
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DAP
1998-04-16
MDA D-DIMER
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DAP
1998-03-10
VIDAS D-DIMER (DD) ASSAY
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DAP
1997-11-04
IL TEST D-DIMER
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DAP
1997-06-26
STA-LIATEST D-DI TEST KIT
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DAP
1997-05-23
STA D-DI CALIBRATOR KIT
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DAP
1995-06-15
MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS
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DAP
1994-09-20
AURATEK FDP
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DAP
1993-11-02
FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
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DAP
1992-08-05
FIBRINOSTIKA TDP MICROELISA SYSTEM
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DAP
1992-07-13
FDP PLASMA TEST KIT
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DAP
1992-01-31
D-DIMER WELLCOTEST (HA10)
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DAP
1992-01-30
FIBRINOGEN FDP CONTROL
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DAP
1991-10-09
FIBRINOSTIKA FBDP MICROELISA SYSTEM
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DAP
1989-03-03
AGEN DIMERTEST EIA
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DAP
1988-08-17
DIMERTEST(R) LATEX
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DAP
1987-08-06
DATA-FI DIMERTEST LATEX ASSAY
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DAP
1986-09-16
ASSERACHROM D-DI KIT
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