Fibrin Split Products
FDA product code GHH · 28 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
- 1979-09-04 – 2013-01-24
GHH
2013-01-24
GHH
2009-05-06
PATHFAST D-DIMER
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GHH
2007-06-11
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
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GHH
2007-03-14
TINA-QUANT D-DIMER TEST SYSTEM
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GHH
2004-11-29
TRIAGE D-DIMER TEST, MODEL 98100
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GHH
2003-04-01
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
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GHH
2002-08-07
MDA D-DIMER
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GHH
2001-05-29
TINA-QUANT D-DIMER TEST SYSTEM
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GHH
1999-12-14
SIMPLIFY D-DIMER, MODEL DCGK1
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GHH
1997-09-09
OPUS D-DIMER
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GHH
1995-10-25
AGEN DIMERTEST GOLD EIA
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GHH
1993-11-03
FDP - SLIDEX DIRECT
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GHH
1992-10-16
MINUTEX D-DIMER LATEX TEST
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GHH
1991-04-12
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
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GHH
1989-08-03
ABBOTT IMX(TM) D-DIMER
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GHH
1989-03-27
ABBOTT TESTPACK(TM) D-DIMER
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GHH
1989-02-07
MODIFIED D-DI-TEST KIT
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GHH
1988-02-09
FIBRINOSTICON
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GHH
1987-07-06
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
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GHH
1986-09-04
D-DI TEST KIT
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GHH
1985-10-10
FDP ASSAY-20 TEST KIT
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GHH
1985-10-04
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
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GHH
1985-09-17
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
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GHH
1985-08-12
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR
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GHH
1985-04-03
DIMERTEST LATEX
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GHH
1981-12-17
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
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GHH
1980-10-10
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
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GHH
1979-09-04
FIBRO-TEC TEST KIT
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