Data / Medical devices / France / Diagnostica Stago - Taverny

Diagnostica Stago - Taverny: FDA-registered device maker in Taverny Val-d'Oise, France, 60 510(k) clearances

Name: Diagnostica Stago - Taverny FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Diagnostica Stago - Taverny is registered with the FDA (registration 9710666) in Taverny Val-d'Oise, France. It lists 24 device types. The FDA files 60 510(k) clearances under its listings, the newest dated December 10, 2016. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 9710666
FEI number: 3003565434
Address: 23/29 rue Constantin Pecqueur, Taverny Val-d'Oise, France, 95150
Owner or operator: Diagnostica Stago (10023909)
Roles: Exporter to the US, Manufacturer
First device listed: December 21, 2007
Registered through: 2027
Brand names listed: Asserachrom D-Di, Asserachrom Free Protein S, Asserachrom HPIA, Asserachrom IX:Ag, Asserachrom PF4, Asserachrom Protein C, Asserachrom Total Protein S, Asserachrom VWF:Ag and more

Devices it lists

Device	Product code	Class	Role	Source
Activated Partial Thromboplastin	GFO	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Aggregrometer, Platelet	JBX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Antithrombin Iii Quantitation	JBQ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Assay, Heparin	KFF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Bothrops Atrox Reagent	JCO	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Control, Plasma, Abnormal	GGC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Conversion To Creatinine, Creatine	JLA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Fibrin Monomer Paracoagulation	JBN	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Fibrin Split Products	GHH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	DAP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Fluid, Diluting, Manual Cell	JCG	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Plasma, Coagulation Factor Deficient	GJT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Plasma, Control, Normal	GIZ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Plasminogen, Antigen, Antiserum, Control	DDX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Platelet Factor 4 Radioimmunoassay	LCO	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Reagent, Russel Viper Venom	GIR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
System, Fibrinogen Determination	KQJ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Test, Qualitative And Quantitative Factor Deficiency	GGP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Test, Thrombin Time	GJA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Test, Time, Partial Thromboplastin	GGW	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Test, Time, Prothrombin	GJS	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 10, 2016	K162227	STA® - Liatest® D-Di	DAP	Substantially Equivalent	Diagnostica Stago	accessdata.fda.gov
December 12, 2014	K142132	POOL NORM	GGN	Substantially Equivalent	Diagnostics Stago S.A.S.	accessdata.fda.gov
September 3, 2014	K141144	STA LIATEST D-DI	DAP	Substantially Equivalent	Diagnostica Stago	accessdata.fda.gov
March 14, 2013	K120014	STA- COAG CONTROL (N+ABN) PLUS	GGN	Substantially Equivalent	Diagnostica Stago, Inc.	accessdata.fda.gov
October 26, 2011	K111822	STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH	KFF	Substantially Equivalent	Diagnostica Stago, Inc.	accessdata.fda.gov
December 6, 2006	K061805	STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM	GIR	Substantially Equivalent	Diagnostica Stago, Inc.	accessdata.fda.gov
July 28, 2006	K061803	STA - CONTROL LA 1+2	GGC	Substantially Equivalent	Diagnostica Stago, Inc.	accessdata.fda.gov
June 6, 2001	K010963	STA-LIATEST FREE PROTEIN S TEST KIT	GGP	Substantially Equivalent	Diagnostica Stago, Inc.	accessdata.fda.gov
April 9, 2001	K010324	STA-QUALITY HBPM/LMWH KIT	GGN	Substantially Equivalent	Diagnostica Stago, Inc.	accessdata.fda.gov
February 12, 2001	K003767	ASSERACHROM HPIA TEST KIT	LCO	Substantially Equivalent	Diagnostica Stago, Inc.	accessdata.fda.gov
August 19, 1997	K971519	ASSERACHROM TPA TEST KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 26, 1997	K964728	STA-LIATEST D-DI TEST KIT	DAP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 26, 1997	K964716	STA LIATEST CONTROL [N]+[P] KIT	GGN	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 25, 1996	K962675	STA - LIATEST VWF TEST KIT	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
September 13, 1996	K962671	STA-VWF CALIBRATOR KIT	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
November 13, 1995	K954040	ASSERACHROM TOTAL PROTEIN S KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
November 13, 1995	K954017	ASSERACHROM FREE PROTEIN S KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
September 26, 1995	K943520	HEPARIN CONTROL KIT	KFF	Unknown	American Bioproducts Co.	accessdata.fda.gov
September 26, 1995	K943519	HBPM/LMWH CONTROL KIT	KFF	Unknown	American Bioproducts Co.	accessdata.fda.gov
September 26, 1995	K943514	THE HEPANORM HBPM/LMWH KIT	KFF	Unknown	American Bioproducts Co.	accessdata.fda.gov
May 23, 1995	K925433	THE STACHROM HEPARIN ASSAY KIT	KFF	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
May 11, 1995	K943517	STACLOT HEPARIN TEST KIT	KFF	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
March 21, 1995	K943518	STA SYSTEM CONTROL [N] + [P] KIT	GGN	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
March 1, 1994	K934606	STAGO FACTOR II-DEFICIENT PLASMA	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
March 1, 1994	K934605	STAGO FACTOR V-DEFICIENT PLASMA	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
November 15, 1993	K933432	STAGO FACTOR IX-DEFICIENT PLASMA	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
November 5, 1993	K931906	NEW STACHROM PROTEIN C TEST KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 27, 1993	K933444	STAGO FACTOR XI-DEFICIENT PLASMA	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 27, 1993	K933441	STAGO FACTOR X-DEFICIENT PLASMA	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 27, 1993	K933440	STAGO FACTOR VII-DEFICIENT PLASMA	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 27, 1993	K933438	STAGO FACTOR XII-DEFICIENT PLASMA	GJT	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
April 27, 1993	K930923	COAG-CONTROL	GGC	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
December 23, 1992	K923731	STACLOT LA TEST KIT	GFO	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
December 7, 1992	K922565	NEOPLASTINE(R) CI KIT	GJS	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 26, 1992	K922174	COAG-CONTROL [N] KIT	GGN	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
July 13, 1992	K920943	FDP PLASMA TEST KIT	DAP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 23, 1992	K922040	NEOPLASTINE CI PLUS	GJS	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 9, 1992	K922021	UNICALIBRATOR KIT	GIZ	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 9, 1992	K921684	PTT-LA TEST KIT	GGW	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 8, 1991	K913424	STACLOT(R) PROTEIN S TEST KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 2, 1991	K912468	LIATEST PROTEIN S KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
January 24, 1991	K905110	LIATEST(R) AT III TEST KIT	JBQ	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 23, 1989	K892859	THE STAGO VIII DEFICIENT PLASMA KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
February 7, 1989	K890399	MODIFIED D-DI-TEST KIT	GHH	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
December 28, 1988	K884384	THROMBIN-PREST REAGENT KIT	GJA	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
October 22, 1986	K862775	ASSERACHROM B-TG KIT	JBX	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
September 16, 1986	K862156	ASSERACHROM D-DI KIT	DAP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
September 4, 1986	K862774	ASSERACHROM PF4 KIT	LCO	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 23, 1986	K861190	PTT AUTOMATE TEST KIT	GGW	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
June 19, 1986	K861079	STACLOT PROTEIN C TEST KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
April 4, 1986	K860371	ASSERACHROM VWF KIT	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
March 6, 1986	K854015	FS TEST KIT	JBN	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
March 3, 1986	K854762	HEPANORM CALIBRATION PLASMA SET	KFF	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
February 4, 1986	K854312	ASSERACHROM IX:AG	GGP	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
January 3, 1986	K854016	ASSERACHROM PROTEIN C KIT	JLA	Substantially Equivalent	American Bioproducts Co.	accessdata.fda.gov
April 23, 1984	K840210	REPTILASE-R HA35	JCO	Substantially Equivalent	Wellcome Diagnostics	accessdata.fda.gov
March 2, 1984	K840211	FIBRI-PREST AUTOMATE HA34	KQJ	Substantially Equivalent	Wellcome Diagnostics	accessdata.fda.gov
November 21, 1983	K832591	DIACROM *PLG	DDX	Substantially Equivalent	Wellcome Diagnostics	accessdata.fda.gov
September 29, 1983	K832592	DIACROM * ATIII	JBQ	Substantially Equivalent	Wellcome Diagnostics	accessdata.fda.gov
November 5, 1979	K792048	LANCER COAGENT APTT KIT	GGW	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov

Compare with other makers

Updated December 10, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.