Plasma, Coagulation Factor Deficient
FDA product code GJT · 79 cleared devices
Class 2
Hematology
- Regulation
- 21 CFR 864.7290
- Review panel
- HE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1988-02-19 – 2023-09-13
GJT
2023-09-13
GJT
2018-03-22
HemosIL Factor XII Deficient Plasma
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GJT
2011-12-19
NOFACT IX
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GJT
2011-12-19
NOFACT VIII
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GJT
2011-07-08
HEMOSIL FACTOR VIII DEFICIENT PLASMA
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GJT
2005-05-02
HEMOSIL FACTOR II DEFICIENT PLASMA
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GJT
2005-02-09
HEMOSIL FACTOR XII DEFICIENT PLASMA
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GJT
2004-07-12
DIAPHARMA FACTOR X KIT
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GJT
2004-02-13
HEMOSIL FACTOR VIII DEFICIENT PLASMA
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GJT
2003-07-31
HEMOSIL FACTOR IX DEFICIENT PLASMA
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GJT
2003-05-19
HEMOSIL FACTOR X DEFICIENT PLASMA
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GJT
2003-03-19
HEMOSIL FACTOR XI DEFICIENT PLASMA
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GJT
2003-02-12
HEMOSIL FACTOR VII DEFICIENT PLASMA
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GJT
2003-01-14
HEMOSIL FACTOR V DEFICIENT PLASMA
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GJT
1999-06-07
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
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GJT
1999-03-18
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
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GJT
1999-02-17
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
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GJT
1999-01-13
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
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GJT
1999-01-13
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
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GJT
1998-10-13
COAGULATION FACTOR V DEFICIENT PLASMA
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GJT
1997-08-13
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
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GJT
1997-07-22
CRYO CHECK FACTOR V DEFICIENT PLASMA
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GJT
1997-07-18
CRYO CHECK FACTOR X DEFICIENT PLASMA
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GJT
1997-07-18
CRYO CHECK FACTOR IX DEFICIENT PLASMA
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GJT
1997-07-17
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
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GJT
1997-07-17
CRYO CHECK FACTOR VII DEFICIENT PLASMA
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GJT
1997-07-14
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
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GJT
1997-04-25
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
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GJT
1997-04-25
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
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GJT
1996-10-25
STA - LIATEST VWF TEST KIT
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GJT
1996-09-13
STA-VWF CALIBRATOR KIT
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GJT
1995-10-20
PROTEIN C DEFICIENT PLASMA
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GJT
1995-05-19
HEMOLAB COFAC IX
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GJT
1995-05-19
BIOMERIEUX HEMOLAB COFAC II
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GJT
1995-01-17
BIOMERIEUX HEMOLAB COFAC X
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GJT
1995-01-17
BIOMERIEUX HEMOLAB COFAC VII
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GJT
1994-03-15
FACTOR VIII DEFICIENT PLASMA
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GJT
1994-03-07
FACTOR
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GJT
1994-03-07
FACTOR VII DEFICIENT PLASMA
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GJT
1994-03-07
FACTOR X DEFICIENT PLASMA
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GJT
1994-03-01
STAGO FACTOR II-DEFICIENT PLASMA
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GJT
1994-03-01
STAGO FACTOR V-DEFICIENT PLASMA
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GJT
1993-11-15
STAGO FACTOR IX-DEFICIENT PLASMA
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GJT
1993-10-27
STAGO FACTOR XI-DEFICIENT PLASMA
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GJT
1993-10-27
STAGO FACTOR X-DEFICIENT PLASMA
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GJT
1993-10-27
STAGO FACTOR VII-DEFICIENT PLASMA
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GJT
1993-10-27
STAGO FACTOR XII-DEFICIENT PLASMA
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GJT
1993-09-15
BIOMERIEUX HEMOLAB COFAC VIII
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GJT
1993-06-08
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
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GJT
1993-05-21
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
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GJT
1992-12-01
CLOTTING FACTOR V DEFICIENT PLASMA
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GJT
1992-05-11
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
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GJT
1991-09-10
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
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GJT
1990-06-15
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
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GJT
1990-05-25
ORTHO CORRECTION REAGENTS
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GJT
1990-03-06
FACTOR II DEFICIENT PLASMA
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GJT
1990-03-06
FACTOR XII DEFICIENT PLASMA
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GJT
1990-03-06
FACTOR XI DEFICIENT PLASMA
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GJT
1990-03-06
FACTOR X DEFICIENT PLASMA
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GJT
1990-03-06
FACTOR IX DEFICIENT PLASMA
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GJT
1990-03-06
FACTOR VIII DEFICIENT PLASMA
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GJT
1990-03-06
FACTOR VII DEFICIENT PLASMA
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GJT
1990-03-06
FACTOR V DEFICIENT PLASMA
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GJT
1990-01-25
FACTOR II DEFICIENT PLASMA
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GJT
1989-10-06
ABNORMAL REFERENCE PLASMA-IX
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GJT
1989-10-06
ABNORMAL REFERENCE PLASMA-VIII
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GJT
1989-06-23
FACTOR XI DEFICIENT PLASMA
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GJT
1989-06-23
FACTOR VII DEFICIENT PLASMA
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GJT
1989-06-23
FACTOR XII DEFICIENT PLASMA
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GJT
1989-06-23
FACTOR V DEFICIENT PLASMA
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GJT
1989-06-23
FACTOR VIII DEFICIENT PLASMA
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GJT
1989-06-23
FACTOR IX DEFICIENT PLASMA
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GJT
1989-06-23
FACTOR X DEFICIENT PLASMA
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GJT
1988-11-01
ORTHO FACTOR VII DEFICIENT PLASMA
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GJT
1988-11-01
ORTHO FACTOR XI DEFICIENT PLASMA
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GJT
1988-11-01
ORTHO FACTOR X DEFICIENT PLASMA
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GJT
1988-11-01
ORTHO FACTOR XII DEFICIENT PLASMA
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GJT
1988-03-17
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
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GJT
1988-02-19
FACTOR VIII REFERENCE PLASMA
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