Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710666

FEI Number

3003565434

Entity Name

Diagnostica Stago - Taverny

City/State/Country

Taverny Val-d'Oise, FR

Establishment Address

23/29 rue Constantin Pecqueur, Taverny Val-d'Oise 95150, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diagnostica Stago (Owner Number: 10023909)

Owner / Operator Contact Address

3 allee Theresa, Asnieres sur Seine, FR-92 92600, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K943519

PMA Number

N/A

All Registered Proprietary Names

PTT Automate STA - PTT A Asserachrom VWF:Ag STA - Heparin Control STA - VWF:Ag Calibrator FDP Plasma Latex Asserachrom D-Di FDP Plasma FDP Plasma Buffer STA - Liatest D-Di STA - Deficient VIII Pool Norm Liatest AT III STA - Staclot Protein S FDP Plasma Buffer FDP Plasma Latex FDP Plasma STA - Deficient II Asserachrom D-Di STA - Liatest Free Protein S STA - Neoplastine CI Plus STA - Liatest Control N + P Asserachrom Free Protein S STA - C.K. Prest C.K. Prest F.S. Test Unit Test cards for F.S. Test and FDP Plasma kits F.S. Test STA - Staclot Protein C Asserachrom b-TG STA - Stachrom Protein C STA - Heparin Control STA - Deficient VIII STA - Quality HBPM/LMWH STA - Multi Hep Calibrator STA - Liquid Anti-Xa STA - Quality HNF/UFH STA - Liatest Control N + P STA - C.K. Prest C.K. Prest STA - Quality HBPM/LMWH STA - Liatest Free Protein S FDP Plasma Latex FDP Plasma Buffer FDP Plasma STA - Hepanorm H STA - Hepanorm HBPM/LMWH Asserachrom PF4 Asserachrom IX:Ag Asserachrom Protein C FDP Plasma STA - Stachrom Protein C Asserachrom IX:Ag Asserachrom tPA STA - Neoplastine CI Plus STA - Deficient X STA - Control LA 1 + 2 Fibri-Prest Automate STA - Fibrinogen Coag Control N + P STA - Deficient XI STA - Thrombin STA - Hepanorm HBPM/LMWH Stachrom Heparin STA - Unicalibrator Unicalibrator STA - Liatest D-Di STA - Deficient II STA - Hepanorm H STA - Deficient XI PTT Automate STA - PTT A STA - Deficient VII STA - Deficient V D-Di Test Test cards for D-Di Test kit STA - Staclot Protein S STA - Coag Control (N + ABN) PLUS STA - HBPM/LMWH Control Asserachrom Protein C Liatest Protein S STA - Fibrinogen Fibri-Prest Automate STA - C.K. Prest C.K. Prest Asserachrom VWF:Ag System Control N + P STA - System Control N + P Asserachrom Total Protein S PTT-LA STA - Deficient VII STA - Staclot Heparin Liatest AT III Asserachrom Washing Solution STA - Staclot Heparin STA - Deficient XII STA - Liatest VWF:Ag STA - Liatest D-Di STA - Deficient V Stachrom Heparin Staclot LA 20 Staclot LA Test cards for D-Di Test kit D-Di Test STA - ImmunoDef VIII STA - ImmunoDef II STA - ImmunoDef IX STA - ImmunoDef XI Asserachrom tPA STA - Control LA 1 + 2 STA - Neoplastine CI System Control N + P STA - System Control N + P Coag Control N + P Staclot LA Staclot LA 20 STA - HBPM/LMWH Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2014-11-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2015-03-04
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2007-12-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-12-28
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-21
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-12-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-12-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-28
JBN	Fibrin Monomer Paracoagulation	Hematology	Class 2	864.7300	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
JBX	Aggregrometer, Platelet	Hematology	Class 2	864.6675	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2011-12-02
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2011-12-02
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-12-02
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-21
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-12-21
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-21
LCO	Platelet Factor 4 Radioimmunoassay	Hematology	Class 2	864.7695	2007-12-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
JLA	Conversion To Creatinine, Creatine	Clinical Chemistry	Class 1	862.1210	2007-12-21
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2017-01-03
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-21
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-21
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-21
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2007-12-21
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-28
GJA	Test, Thrombin Time	Hematology	Class 2	864.7875	2007-12-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-28
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2007-12-21
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-12-28
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-12-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-21
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-21
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-21
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2013-04-15
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-21
JLA	Conversion To Creatinine, Creatine	Clinical Chemistry	Class 1	862.1210	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
KQJ	System, Fibrinogen Determination	Hematology	Class 2	864.7340	2007-12-28
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-21
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-28
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-28
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-28
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-28
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2007-12-28
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2011-04-22
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-28
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-12-21
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2007-12-28
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2007-12-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-21
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-28
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2007-12-21
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2018-09-07
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2007-12-21
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-28
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-28
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2008-11-18
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-21
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2007-12-21
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2007-12-21
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2007-12-21
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2007-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

Donald KRAFT Business: DIAGNOSTICA STAGO, INC Email: donald.kraft@us.stago.com Phone: (973) 6311200

Related Public Records

Same Entity

Diagnostica Stago

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043723	Diagnostica Stago - Gennevilliers	Gennevilliers Hauts-de-Seine, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

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3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710666. Last updated year: 2026. Please use registration number 9710666 when referencing this establishment in official correspondence.