Test, Qualitative And Quantitative Factor Deficiency
FDA product code GGP · 189 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
- 1977-02-07 – 2025-08-25
GGP
2025-08-25
GGP
2023-12-13
HemosIL Chromogenic Factor IX
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GGP
2023-06-02
vWF Ag
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GGP
2022-12-23
CRYOcheck Chromogenic Factor IX
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GGP
2022-12-09
HemosIL von Willebrand Factor Antigen
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GGP
2020-08-19
HemosIL von Willebrand Factor Antigen
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GGP
2020-07-17
Cryocheck Chromogenic Factor VIII
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GGP
2019-03-12
CRYOcheck FVIII Inhibitor Kit
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GGP
2018-09-07
INNOVANCE Free PS Ag
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GGP
2011-03-17
HEMOSIL PROTEIN S ACTIVITY ASSAY
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GGP
2009-12-22
STA LIATEST FREE PS
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GGP
2008-12-17
THROMBO TEK PSE, MODEL 90-480
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GGP
2008-11-20
FACTOR VIII ANTIBODY SCREEN
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GGP
2007-08-15
SPECTROLYSE PAI-1, MODEL 101201
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GGP
2007-03-29
HEMOSIL PROCLOT
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GGP
2007-01-29
TRIAGE PROTEIN C TEST
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GGP
2006-09-01
HEMOSIL PROTEIN C
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GGP
2006-01-20
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
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GGP
2006-01-13
HEMOSIL PROS
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GGP
2005-12-27
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
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GGP
2005-09-23
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
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GGP
2005-06-29
VISULIZE FACTOR IX ANTIGEN KIT
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GGP
2005-03-18
CRYOCHECK CLOT S
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GGP
2004-12-02
COATEST SP FVIII
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GGP
2004-06-18
CRYOCHECK CLOT C
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GGP
2004-04-30
HEMOSIL VON WILLEBRAND ACTIVITY
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GGP
2004-04-05
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
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GGP
2003-12-15
MODIFICATION TO COATEST FACTOR VIII
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GGP
2003-03-19
CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
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GGP
2002-08-27
PROTEIN S AC
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GGP
2002-03-13
IMUBIND TPA ELISA, MODEL 860
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GGP
2002-03-07
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
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GGP
2001-09-14
ACTICLOT PROTEIN S, MODEL 843L
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GGP
2001-06-25
IL TEST PROS
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GGP
2001-06-06
STA-LIATEST FREE PROTEIN S TEST KIT
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GGP
2001-04-13
IL TEST FREE PROTEIN S
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GGP
2000-10-13
COALIZA PROTEIN S-FREE
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GGP
2000-10-05
REFACTO LABORATORY STANDARD
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GGP
2000-09-26
PROTEIN C REAGENT
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GGP
2000-04-25
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
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GGP
2000-04-17
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
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GGP
2000-02-01
GTI-FVIII INHIBITOR ASSAY
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GGP
1999-11-01
IL TEST VON WILLEBRAND FACTOR
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GGP
1999-01-06
BIOCLOT APC SENSITIVITY
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GGP
1998-12-22
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
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GGP
1998-10-22
VFE
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GGP
1998-09-28
COAMATIC PLASMIN INHIBITOR
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GGP
1998-08-27
IL TEST PLASMIN INHIBITOR
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GGP
1998-08-21
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
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GGP
1998-05-26
IL TEST PLASMINOGEN
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GGP
1998-05-01
COAMATIC PLASMINOGEN
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GGP
1998-04-21
IL TEST PROTEIN C
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GGP
1998-04-16
COAMATIC FACTOR VIII
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GGP
1997-10-20
N-ASSAY TIA PLASMINOGEN TEST KIT
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GGP
1997-10-06
REAADS PROTEIN C ANTIGEN TEST KIT
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GGP
1997-09-25
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
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GGP
1997-08-19
ASSERACHROM TPA TEST KIT
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GGP
1997-08-13
REAADS PROTEIN S ANTIGEN TEST KIT
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GGP
1997-08-13
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
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GGP
1997-07-25
VON WILLEBRAND REAGENT
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GGP
1997-07-14
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
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GGP
1997-04-21
HUMAN PROTEIN S RID TEST KIT
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GGP
1996-12-18
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
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GGP
1996-12-18
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
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GGP
1996-12-13
PROC APC ASSAY, PROC CONTROL PLASMA
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GGP
1996-11-18
CHROMOLIZE PAI-1 KIT
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GGP
1996-11-15
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
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GGP
1996-10-10
FACTOR DEFICIENT PLASMA
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GGP
1996-07-31
CHROMOLIZE TPA ASSAY KIT
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GGP
1996-06-05
TINTELIZE PAI-1 KIT
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GGP
1996-02-29
BIOCLOT PROTEIN S
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GGP
1996-02-29
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
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GGP
1996-02-09
CHROM Z-F:VIII, CAT. NO. 5241
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GGP
1996-01-30
CHROM Z-PROTEIN C, CAT. NO. 5243
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GGP
1995-12-07
CHROM Z-PLASMINOGEN, CAT. NO. 5244
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GGP
1995-11-13
ASSERACHROM TOTAL PROTEIN S KIT
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GGP
1995-11-13
ASSERACHROM FREE PROTEIN S KIT
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GGP
1995-11-06
COAMATIC FACTOR VIII
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GGP
1995-09-25
SPECTROLYSE ANTIPLASMIN KIT
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GGP
1995-07-13
BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
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GGP
1995-03-06
HUMAN PROTEIN C RID TEST KIT
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GGP
1995-01-24
PROTEIN C REAGENT, COAGULOMETRIC
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GGP
1995-01-11
RISTOCETIN COFACTOR ASSAY KIT
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GGP
1994-12-22
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
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GGP
1994-02-23
TINTELIZER(R) TPA
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GGP
1994-01-27
MDA PROTEIN ASSAY
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GGP
1993-12-06
SPECTROLYSE FACTOR VII:C
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GGP
1993-11-05
NEW STACHROM PROTEIN C TEST KIT
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GGP
1993-09-02
HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY
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GGP
1993-04-12
IL TEST(TM) PROTEIN S
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GGP
1993-01-14
IL TEST(TM) PRO-CHROM
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GGP
1992-12-07
COAMATE PROTEIN C CHROMOGENIC ASSAY
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GGP
1992-10-09
SPECTROLYSE/PL PAI KIT
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GGP
1992-09-23
NEW STACHROM ANTIPLASMIN
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GGP
1992-08-12
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
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GGP
1992-04-17
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
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GGP
1992-01-15
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
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GGP
1992-01-06
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
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GGP
1991-12-09
SPECTROLYSE PROTEIN C KIT
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GGP
1991-10-09
IL TEST PROCLOT ASSAY STYSTEM
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