Diagnostica Stago Inc

FDA Filings

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

Diagnostica Stago Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• AFFINITY BIOLOGICALS INC.
• Donald KRAFT
• Diagnostica Stago - Taverny

FDA Registration(s)

• Registration Number: 2245451
• FEI Number: 2245451
• Name: DIAGNOSTICA STAGO, INC.
• Owner & Operator: Stago B.V.
• Contact Address: Locatellikade 1 Parnassustoren ; Amsterdam NL-NOTA 1076 AZ NL
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5 Century Dr ; PARSIPPANY, NJ 07054 US
• Establishment Type: Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GJS DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - NeoPTimal 5	2019-05-02
GJS DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - NeoPTimal 20	2019-05-02
GJS DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - NeoPTimal 10	2019-05-02
JPA DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA Satellite MAX	2018-10-22
JPA DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA R Max	2018-10-22
JPA DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA R Max 3	2018-10-22
JPA DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA R Max 3 plus cap piercing	2018-10-22
JPA DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA R Max + cap piercing	2018-10-22
JPA DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA Compact Max 3	2018-10-22
JPA DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA Compact Max 3 + cap piercing	2018-10-22
GJT DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - ImmunoDef XII	2018-09-17
GJT DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - ImmunoDef XI	2018-09-17
GJT DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - ImmunoDef VIII	2018-09-17
GJT DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - ImmunoDef IX	2018-09-17
GJT DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - ImmunoDef II	2018-09-17
GGN DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - Dabigatran Control	2018-09-17
GGN DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - Dabigatran Calibrator	2018-09-17
GKP DIAGNOSTICA STAGO, INC. [Stago B.V.]	ST art	2017-08-07
OTR DIAGNOSTICA STAGO, INC. [Stago B.V.]	Asserachrom APA Screen	2017-01-04
OTR DIAGNOSTICA STAGO, INC. [Stago B.V.]	Asserachrom APA IgG,M	2017-01-04
OHQ DIAGNOSTICA STAGO, INC. [Stago B.V.]	Coag-Path	2017-01-04
OHQ DIAGNOSTICA STAGO, INC. [Stago B.V.]	Coag-Norm	2017-01-04
KQJ DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - Fib 2	2017-01-04
JJX DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - Fondaparinux Control	2017-01-04
JJX DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - FM Control	2017-01-04
JIT DIAGNOSTICA STAGO, INC. [Stago B.V.]	TriniCAL INR & Quick	2017-01-04
JIT DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - Fondaparinux Calibrator	2017-01-04
JIT DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - FM Calibrator	2017-01-04
JIT DIAGNOSTICA STAGO, INC. [Stago B.V.]	Etaloquick	2017-01-04
JBN DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - Liatest FM	2017-01-04
GGW DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - Staclot APC-R	2017-01-04
GGP DIAGNOSTICA STAGO, INC. [Stago B.V.]	Stachrom PAI	2017-01-04
GGP DIAGNOSTICA STAGO, INC. [Stago B.V.]	STA - VWF:Rco	2017-01-04
GGP DIAGNOSTICA STAGO, INC. [Stago B.V.]	Facteur XIII Reactifs	2017-01-04
GGP DIAGNOSTICA STAGO, INC. [Stago B.V.]	Asserachrom VWF:FVIIIB	2017-01-04
GGP DIAGNOSTICA STAGO, INC. [Stago B.V.]	Asserachrom VWF:CB	2017-01-04
GGP DIAGNOSTICA STAGO, INC. [Stago B.V.]	Asserachrom PAI-1	2017-01-04
DBL DIAGNOSTICA STAGO, INC. [Stago B.V.]	Asserachrom HPIA - IgG	2017-01-04
PMN K120014 DIAGNOSTICA STAGO, INC.	STA- COAG CONTROL (N+ABN) PLUS	2013-03-14
PMN K130090 DIAGNOSTICA STAGO, INCORPORATED	STA COMPACT MAX	2013-02-12
PMN K111822 DIAGNOSTICA STAGO, INC.	STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH	2011-10-26
PMN K092937 DIAGNOSTICA STAGO, INC.	STA-HYBRID HEP CALIBRATOR	2010-08-02
PMN K093167 DIAGNOSTICA STAGO, INC.	STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER	2009-12-22
PMN K092170 DIAGNOSTICA STAGO, INC.	STA LIATEST FREE PS	2009-12-22
PMN K093001 DIAGNOSTICA STAGO, INCORPORATED	STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER	2009-12-18
PMN K092113 DIAGNOSTICA STAGO, INC.	STA - FREE PS CALIBRATOR	2009-11-13
PMN K082248 DIAGNOSTICA STAGO, INC.	STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER	2008-12-12
PMN K082675 DIAGNOSTICA STAGO, INC.	STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER	2008-10-10
PMN K061805 DIAGNOSTICA STAGO, INC.	STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM	2006-12-06
PMN K061803 DIAGNOSTICA STAGO, INC.	STA - CONTROL LA 1+2	2006-07-28
PMN K053111 DIAGNOSTICA STAGO, INC.	STA-CEPHASCREEN KIT	2006-05-04
PMN K010963 DIAGNOSTICA STAGO, INC.	STA-LIATEST FREE PROTEIN S TEST KIT	2001-06-06
PMN K010350 DIAGNOSTICA STAGO, INC.	STA -CALIBRATOR HBPM/LMWH KIT	2001-04-09
PMN K010324 DIAGNOSTICA STAGO, INC.	STA-QUALITY HBPM/LMWH KIT	2001-04-09
PMN K003767 DIAGNOSTICA STAGO, INC.	ASSERACHROM HPIA TEST KIT	2001-02-12

Related Finance Registrations

NCAGE Code	0TH01	DIAGNOSTICA STAGO INC.
CAGE Code	0TH01	DIAGNOSTICA STAGO INC.
S.A.M. Registration	0TH01 [150587194]	DIAGNOSTICA STAGO INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018112961136	Le Havre,France -> New York/Newark Area, Newark, New Jersey	FREIGHT PREPAID COAGULATION REAGENTS AND SPARE PARTS FOR COAG ATION ANALYSERS HS CODES 9027905000	34 PCS