Donald Kraft

FDA Filings

This page includes the latest FDA filings for Donald Kraft. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003943960
FEI Number3003943960
NameDonald Kraft
Owner & OperatorTcoag Deutschland GmbH
Contact AddressLehbrinkweg 59 32657, Lemgo
N/A DE-NW Nordrhein-Westfalen N/A DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Century Dr New Jersey
Parsippany, NJ 07054 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device

Registration Number9610666
FEI Number3002806856
NameDonald KRAFT
Owner & OperatorDiagnostica Stago
Contact AddressDiagnostica Stago 3 allee Theresa
Asnieres sur Seine FR-92 Hauts-de-Seine 92600 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Century Dr
Parsippany, NJ 07054 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number8043723
FEI Number3001573851
NameDonald KRAFT
Owner & OperatorDiagnostica Stago
Contact AddressDiagnostica Stago 3 allee Theresa
Asnieres sur Seine FR-92 Hauts-de-Seine 92600 FR
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Century Dr
Parsippany, NJ 07054 US
Establishment TypeManufacture Medical Device

Registration Number3008386529
FEI Number3008386529
NameDonald Kraft
Owner & OperatorTcoag Ireland Limited
Contact AddressIDA Business Park, Southern Cross Road Bray, Co. Wicklow
N/A IE-WW Wicklow N/A IE
US Agent
Importing Logistics Registration
ImporterCollege of American Pathologists
Address325 Waukegan Road Northfield, IL 60093-2750
Northfield, IL 60093 UNITED STATES
Importer TypeProficiency testing laboratory
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Century Dr Parsippany
Parsippany, NJ 07054 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Donald Kraft [Tcoag Ireland Limited]
Destiny System Fluid2016-02-05
Donald KRAFT [Diagnostica Stago]
STA R Max2015-08-17
Donald KRAFT [Diagnostica Stago]
STA Coag Expert2013-07-08
Donald KRAFT [Diagnostica Stago]
STA Coag ConneXion2013-07-08
Donald KRAFT [Diagnostica Stago]
STA Compact Max2013-03-05
Donald Kraft [Tcoag Ireland Limited]
Control material (unlabelled)2012-05-25
Donald Kraft [Tcoag Ireland Limited]
STA - Desorb U (00975)2012-02-29
Donald Kraft [Tcoag Ireland Limited]
STA - Cleaner Solution (00973)2012-02-29
Donald Kraft [Tcoag Ireland Limited]
Destiny Prowash (DPW10/DPW20)2012-02-29
Donald Kraft [Tcoag Ireland Limited]
DT Wash (DTW)2012-02-29
Donald Kraft [Tcoag Ireland Limited]
DT Fluid (DTF)2012-02-29
Donald Kraft [Tcoag Deutschland GmbH]
Wash Solution BX850132012-02-29
Donald Kraft [Tcoag Deutschland GmbH]
Enzyclean2012-02-29
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK Level 32012-02-29
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK Level 22012-02-29
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK Level 12012-02-29
Donald Kraft [Tcoag Ireland Limited]
MDA Verify III2010-11-15
Donald Kraft [Tcoag Ireland Limited]
MDA Verify II2010-11-15
Donald Kraft [Tcoag Ireland Limited]
MDA Verify 12010-11-15
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Automated aPTT 6ml2010-11-15
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Automated aPTT 3ml2010-11-15
Donald Kraft [Tcoag Ireland Limited]
TriniVeriCAL2010-11-10
Donald Kraft [Tcoag Ireland Limited]
MDA Imidazole Buffer2010-11-08
Donald Kraft [Tcoag Ireland Limited]
MDA D-Dimer2010-11-08
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor VIII2010-10-26
Donald Kraft [Tcoag Deutschland GmbH]
KC4 Delta2010-06-09
Donald Kraft [Tcoag Deutschland GmbH]
KC1 Delta2010-06-09
Donald Kraft [Tcoag Deutschland GmbH]
Destiny MAX Analyzer2010-06-09
Donald Kraft [Tcoag Deutschland GmbH]
Destiny Plus2010-06-09
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT PT HTF 10 x 6ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT PT HTF 10 x 20ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHROM Antithrombin IIa2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Imidazole Buffer2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Fibrinogen Kit2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCAL Fibrinogen2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniLIZE PAI-1 Activity2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniLIZE tPA Activity2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniLIZE Stabilyte tubes2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK Lupus Positive control2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHROM Antithrombin Xa2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniLIZE PAI-1 Antigen2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHROM Antithrombin IIa2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHROM Factor VIII: C2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCAL Reference Plasma2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT aPTT S 5 x 3ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT aPTT S 5 x 10ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
Ristocetin Cofactor Assay2010-05-28
Donald Kraft [Tcoag Ireland Limited]
Platelets Lyophilized(Diluent)2010-05-28
Donald Kraft [Tcoag Ireland Limited]
ADP 0.2M2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK Abnormal control2010-05-28
Donald Kraft [Tcoag Ireland Limited]
Ristocetin2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor II2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Thrombin 10 x 4ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Thrombin 10 x 1ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Calcium Chloride (0.025M)2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor XI2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor VIII2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor VII2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor XII2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor V2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor IX2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Factor X2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT PT Excel S 5 x 20ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT PT Excel S 10 x 6ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT aPTT HS 10 x 3ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT aPTT HS 10 x 10ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCAL Reference Plasma2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT PT excel 10 x 6ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT PT Excel 5 x 20ml2010-05-28
Donald Kraft [Tcoag Ireland Limited]
MDA Fibriquik2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK D-Dimer 32010-05-28
Donald Kraft [Tcoag Ireland Limited]
D-Dimer Control Level 32010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK D-Dimer 22010-05-28
Donald Kraft [Tcoag Ireland Limited]
D-Dimer Control Level 22010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCHECK D-Dimer 12010-05-28
Donald Kraft [Tcoag Ireland Limited]
D-Dimer Control Level 12010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniLIA D-Dimer2010-05-28
Donald Kraft [Tcoag Ireland Limited]
Auto D-Dimer Kit2010-05-28
Donald Kraft [Tcoag Ireland Limited]
Auto D-Dimer Calibrator2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Lupus Confirm2010-05-28
Donald Kraft [Tcoag Ireland Limited]
Accuclot DRVVT Confirm2010-05-28
Donald Kraft [Tcoag Ireland Limited]
TriniCLOT Lupus Screen2010-05-28
Donald Kraft [Tcoag Ireland Limited]
Accuclot DRVVT Screen2010-05-28
Donald KRAFT [Diagnostica Stago]
STA Compact2010-04-23
Donald KRAFT [Diagnostica Stago]
STA-R Evolution Expert Series2010-04-23
Donald KRAFT [Diagnostica Stago]
STA Satellite2009-12-17
Donald KRAFT [Diagnostica Stago]
Neoplastine CI, STA - Neoplastine CI2008-11-18
Donald KRAFT [Diagnostica Stago]
STA-R Evolution2008-11-18
Donald KRAFT [Diagnostica Stago]
Asserachrom tPA2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Liatest D-Di2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Liatest Control N + P2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Liatest VWF:Ag2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - VWF:Ag Calibrator2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom Total Protein S2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom Free Protein S2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Heparin Control2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - HBPM/LMWH Control2007-12-28
Donald KRAFT [Diagnostica Stago]
System Control N + P, STA - System Control N + P2007-12-28
Donald KRAFT [Diagnostica Stago]
System Control N + P, STA - System Control N + P2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Staclot Heparin2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Hepanorm HBPM/LMWH2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient II2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient II2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient V2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient V2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient XI2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient VII2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient XII2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient IX2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Stachrom Protein C2007-12-28
Donald KRAFT [Diagnostica Stago]
Coag Control P, STA - Coag Control P, STA - Coag Control ABN2007-12-28
Donald KRAFT [Diagnostica Stago]
Stachrom Heparin2007-12-28
Donald KRAFT [Diagnostica Stago]
Staclot LA2007-12-28
Donald KRAFT [Diagnostica Stago]
Neoplastine CI Plus, STA - Neoplastine CI Plus2007-12-28
Donald KRAFT [Diagnostica Stago]
Unicalibrator, STA - Unicalibrator2007-12-28
Donald KRAFT [Diagnostica Stago]
PTT-LA2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Stachrom Antiplasmin2007-12-28
Donald KRAFT [Diagnostica Stago]
FDP Plasma, FDP Plasma Latex2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Staclot Protein S2007-12-28
Donald KRAFT [Diagnostica Stago]
Liatest AT III2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Deficient VIII2007-12-28
Donald KRAFT [Diagnostica Stago]
D-Di Test2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Thrombin2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom b-TG2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom PF42007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom D-Di2007-12-28
Donald KRAFT [Diagnostica Stago]
PTT Automate, STA - PTT A2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Staclot Protein C2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom VWF:Ag2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Hepanorm H2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom IX:Ag2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom Protein C2007-12-28
Donald KRAFT [Diagnostica Stago]
F.S. Test/F.S. Test Unit2007-12-28
Donald KRAFT [Diagnostica Stago]
Fibri-Prest Automate, STA - Fibrinogen2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Reptilase2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Stachrom AT III2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Stachrom Plasminogen2007-12-28
Donald KRAFT [Diagnostica Stago]
Fibrinogen Calibrator2007-12-28
Donald KRAFT [Diagnostica Stago]
C.K. Prest, STA - C.K. Prest2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Staclot dRVV Screen, STA - Staclot dRVV Confirm2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Control LA 1 + 22007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Control LA 1 + 22007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Cephascreen2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Liatest Free Protein S2007-12-28
Donald KRAFT [Diagnostica Stago]
STA - Quality HBPM/LMWH2007-12-28
Donald KRAFT [Diagnostica Stago]
Asserachrom HPIA2007-12-28
Donald KRAFT [Diagnostica Stago]
STA-R2007-12-20
Donald KRAFT [Diagnostica Stago]
STA Compact2007-12-20
Donald KRAFT [Diagnostica Stago]
STA2007-12-20
Donald KRAFT [Diagnostica Stago]
ST art2007-12-20

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