DIAGNOSTICA-STAGO

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2245451	2245451	DIAGNOSTICA STAGO, INC.	1	Y	2026-01-01	5 Century Dr PARSIPPANY NJ US 07054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
12815	1945733023	K983460	STAR AUTOMATED MULTI-PARAMETRIC ANALYZER	JPA	1998-11-12
12815	1098937832	K972144	SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III	JBQ	1997-07-25
12815	1022150875	K971858	SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)	KQJ	1997-10-09
12815	2039214982	K971519	ASSERACHROM TPA TEST KIT	GGP	1997-08-19
12815	1537136050	K964728	STA-LIATEST D-DI TEST KIT	DAP	1997-06-26
12815	1363400660	K964716	STA LIATEST CONTROL [N]+[P] KIT	GGN	1997-06-26
12815	1635391912	K963106	CHROMOLIZE PAI-1 KIT	GGP	1996-11-18
12815	1112711062	K962675	STA - LIATEST VWF TEST KIT	GJT	1996-10-25
12815	1095521045	K962671	STA-VWF CALIBRATOR KIT	GJT	1996-09-13
12815	1845622950	K961370	LA POSITIVE CONTROL PLASMA	GGC	1996-05-24
12815	1773501132	K960871	SPECTROLYSE ANTITHROMBIN III (ANTI-XA)	JBQ	1996-08-14
12815	2016016391	K960438	TINTELIZE PAI-1 KIT	GGP	1996-06-05
12815	1665585574	K955735	KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM	JPA	1996-03-11
12815	1976151758	K955724	KC 1A COAGULATION ANALYZER/SET	JPA	1996-03-12
12815	1001738108	K954040	ASSERACHROM TOTAL PROTEIN S KIT	GGP	1995-11-13
12815	1509616152	K954017	ASSERACHROM FREE PROTEIN S KIT	GGP	1995-11-13
12815	1508059538	K943520	HEPARIN CONTROL KIT	KFF	1995-09-26
12815	1736180639	K943519	HBPM/LMWH CONTROL KIT	KFF	1995-09-26
12815	1830515036	K943518	STA SYSTEM CONTROL [N] + [P] KIT	GGN	1995-03-21
12815	2034422045	K943517	STACLOT HEPARIN TEST KIT	KFF	1995-05-11
12815	1856805363	K943514	THE HEPANORM HBPM/LMWH KIT	KFF	1995-09-26
12815	1034218688	K935308	ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY	JBQ	1994-05-17
12815	1874520351	K934606	STAGO FACTOR II-DEFICIENT PLASMA	GJT	1994-03-01
12815	1065380357	K934605	STAGO FACTOR V-DEFICIENT PLASMA	GJT	1994-03-01
12815	1636436368	K934584	SPECTROLYSE FACTOR VII:C	GGP	1993-12-06
12815	1839075101	K933444	STAGO FACTOR XI-DEFICIENT PLASMA	GJT	1993-10-27
12815	1084803940	K933441	STAGO FACTOR X-DEFICIENT PLASMA	GJT	1993-10-27
12815	1662247960	K933440	STAGO FACTOR VII-DEFICIENT PLASMA	GJT	1993-10-27
12815	1815643308	K933438	STAGO FACTOR XII-DEFICIENT PLASMA	GJT	1993-10-27
12815	1850070908	K933432	STAGO FACTOR IX-DEFICIENT PLASMA	GJT	1993-11-15
12815	1250584717	K931906	NEW STACHROM PROTEIN C TEST KIT	GGP	1993-11-05
12815	1593194049	K930849	VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA	JPA	1993-04-20
12815	1289486298	K925433	THE STACHROM HEPARIN ASSAY KIT	KFF	1995-05-23
12815	1138293322	K923731	STACLOT LA TEST KIT	GFO	1992-12-23
12815	1387114534	K922040	NEOPLASTINE CI PLUS	GJS	1992-06-23
12815	2006490364	K922021	UNICALIBRATOR KIT	GIZ	1992-06-09
12815	1240943272	K921684	PTT-LA TEST KIT	GGW	1992-06-09
12815	1996366580	K921396	PLATELIN L	GFO	1992-10-19
12815	1317034485	K920943	FDP PLASMA TEST KIT	DAP	1992-07-13
12815	1710624300	K920668	MINUTEX D-DIMER LATEX TEST	GHH	1992-10-16
12815	1125318842	K913424	STACLOT(R) PROTEIN S TEST KIT	GGP	1991-10-08
12815	1907700169	K912468	LIATEST PROTEIN S KIT	GGP	1991-10-02
12815	1387255272	K905110	LIATEST(R) AT III TEST KIT	JBQ	1991-01-24
12815	1614647141	K904297	ST-4 COAGULATION INSTRUMENT	GKP	1990-11-13
12815	2005892688	K904073	COAGULATION REFERENCE PLASMA, ABNORMAL	GGC	1990-10-22
12815	1365440783	K900792	RISTOCETIN	GHR	1990-03-27
12815	1749202232	K900133	FACTOR II DEFICIENT PLASMA	GJT	1990-01-25
12815	1689668347	K896052	FIBRINOGEN ASSAY KIT	KQJ	1989-11-09
12815	1990061419	K895255	APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT	GFO	1989-10-06
12815	1922445071	K893536	FACTOR XI DEFICIENT PLASMA	GJT	1989-06-23
12815	1236042507	K893535	FACTOR VII DEFICIENT PLASMA	GJT	1989-06-23
12815	1799876530	K893534	FACTOR XII DEFICIENT PLASMA	GJT	1989-06-23
12815	1770430493	K893533	FACTOR V DEFICIENT PLASMA	GJT	1989-06-23
12815	1005896485	K893525	FACTOR VIII DEFICIENT PLASMA	GJT	1989-06-23
12815	1837913951	K893524
12815	1274241156	K893523	FACTOR X DEFICIENT PLASMA	GJT	1989-06-23
12815	1732008258	K892859	THE STAGO VIII DEFICIENT PLASMA KIT	GGP	1989-06-23
12815	1945189704	K890399	MODIFIED D-DI-TEST KIT	GHH	1989-02-07
12815	2048998575	K884384	THROMBIN-PREST REAGENT KIT	GJA	1988-12-28
12815	2048443433	K882214	SIMPLASTIN EXCEL S	GJS	1988-07-01
12815	1366832029	K881999	PLATELIN(R) EXCEL L	GIT	1988-08-17
12815	1015225843	K881348	VERIFY(R) REFERENCE PLASMA	GGN	1988-05-02
12815	1068788677	K862775	ASSERACHROM B-TG KIT	JBX	1986-10-22
12815	1783293435	K862774	ASSERACHROM PF4 KIT	LCO	1986-09-04
12815	1651285619	K862156	ASSERACHROM D-DI KIT	DAP	1986-09-16
12815	1226612764	K861190	PTT AUTOMATE TEST KIT	GGW	1986-06-23
12815	1516138023	K861079	STACLOT PROTEIN C TEST KIT	GGP	1986-06-19
12815	1051177074	K860371	ASSERACHROM VWF KIT	GGP	1986-04-04
12815	1869949899	K854762	HEPANORM CALIBRATION PLASMA SET	KFF	1986-03-03
12815	1996960623	K854312	ASSERACHROM IX:AG	GGP	1986-02-04
12815	1928049328	K854016	ASSERACHROM PROTEIN C KIT	JLA	1986-01-03
12815	1415738426	K854015	FS TEST KIT	JBN	1986-03-06
12815	1259192058	K840210	REPTILASE-R HA35	JCO	1984-04-23
12815	1123547812	K832592	DIACROM * ATIII	JBQ	1983-09-29
12815	1139524419	K832591	DIACROM *PLG	DDX	1983-11-21
12815	1829959522	K792048	LANCER COAGENT APTT KIT	GGW	1979-11-05
12815	1408132768	K253658	STA Satellite Max®	JPA	2026-04-27
12815	1755983944	K212183	STA R Max 3, STA Compact Max 3	JPA	2023-06-07
12815	2039002170	K211485	STA- NeoPTimal	GJS	2022-12-23
12815	1753315083	K162227	STA® - Liatest® D-Di	DAP	2016-12-10
12815	1847527271	K151867	STA R MAX	JPA	2015-08-07
12815	2062725508	K142132	POOL NORM	GGN	2014-12-12
12815	1148199279	K141144	STA LIATEST D-DI	DAP	2014-09-03
12815	1299103529	K130090	STA COMPACT MAX	JPA	2013-02-12
12815	1393879888	K120014	STA- COAG CONTROL (N+ABN) PLUS	GGN	2013-03-14
12815	1463770790	K111822	STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH	KFF	2011-10-26
12815	1756846294	K093001	STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER	JPA	2009-12-18
12815	1689674266	K083896	DESTINY MAX COAGULATION ANALYZER	JPA	2009-07-02
12815	1305651916	K082675	STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER	JPA	2008-10-10
12815	1292817362	K082248	STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER	JPA	2008-12-12
12815	1600743092	K061805	STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM	GIR	2006-12-06
12815	2041829645	K061803	STA - CONTROL LA 1+2	GGC	2006-07-28
12815	1350392470	K021162	AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED	JPA	2002-08-30
12815	1359172199	K013545	SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221	DAP	2001-11-15
12815	1486864239	K013544	SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096	DAP	2001-11-15
12815	1816255160	K010963	STA-LIATEST FREE PROTEIN S TEST KIT	GGP	2001-06-06
12815	1990174275	K010324	STA-QUALITY HBPM/LMWH KIT	GGN	2001-04-09
12815	1127993591	K003767	ASSERACHROM HPIA TEST KIT	LCO	2001-02-12
12815	1747703001	K003328	ACCUCLOT CONTROL I, MODEL A4089	GIZ	2001-03-01
12815	1950020152	K003267	SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A	DAP	2001-03-15
12815	1589056868	K000528	ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119	GIR	2000-04-07
12815	1069202138	K000527	ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094	GIR	2000-04-07
12815	1072051842
12815	1275881701
12815	1587247537
12815	1621739274
12815	1185867223
12815	1190258856
12815	1287536513
12815	1369604470
12815	1406958700
12815	1539457471
12815	1578526794
12815	1624906785
12815	1657395856
12815	1764704448
12815	1791485905
12815	1915343258
12815	2011658594

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GJT	16	1996-10-25
GGP	14	2001-06-06
JPA	13	2026-04-27
DAP	8	2016-12-10
KFF	7	2011-10-26
GGN	6	2014-12-12
JBQ	5	1997-07-25
GJS	3	2022-12-23
GIR	3	2006-12-06
GGC	3	2006-07-28
GFO	3	1992-12-23
GGW	3	1992-06-09
GIZ	2	2001-03-01
LCO	2	2001-02-12
KQJ	2	1997-10-09
GHH	2	1992-10-16
GKP	1	1990-11-13
GHR	1	1990-03-27
GJA	1	1988-12-28
GIT	1	1988-08-17
JBX	1	1986-10-22
JBN	1	1986-03-06
JLA	1	1986-01-03
JCO	1	1984-04-23
DDX	1	1983-11-21

PMN#

STA R Max 3, STA Compact Max 3
2023-06-07
Diagnostica Stago S.A.S
STA- NeoPTimal
2022-12-23
Diagnostica Stago S.A.S
STA® - Liatest® D-Di
2016-12-10
Diagnostica Stago
STA R MAX
2015-08-07
DIAGNOSTICA STAGO S.A.S.
STA LIATEST D-DI
2014-09-03
DIAGNOSTICA STAGO
STA- COAG CONTROL (N+ABN) PLUS
2013-03-14
DIAGNOSTICA STAGO, INC.
STA COMPACT MAX
2013-02-12
DIAGNOSTICA STAGO, INCORPORATED
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
2011-10-26
DIAGNOSTICA STAGO, INC.
STA-HYBRID HEP CALIBRATOR
2010-08-02
DIAGNOSTICA STAGO, INC.
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
2009-12-22
DIAGNOSTICA STAGO, INC.
STA LIATEST FREE PS
2009-12-22
DIAGNOSTICA STAGO, INC.
STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
2009-12-18
DIAGNOSTICA STAGO, INCORPORATED
STA - FREE PS CALIBRATOR
2009-11-13
DIAGNOSTICA STAGO, INC.
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
2008-12-12
DIAGNOSTICA STAGO, INC.
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
2008-10-10
DIAGNOSTICA STAGO, INC.
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
2006-12-06
DIAGNOSTICA STAGO, INC.
STA - CONTROL LA 1+2
2006-07-28
DIAGNOSTICA STAGO, INC.
STA-CEPHASCREEN KIT
2006-05-04
DIAGNOSTICA STAGO, INC.
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
2001-06-07
DIAGNOSTICA-STAGO
STA-LIATEST FREE PROTEIN S TEST KIT
2001-06-06
DIAGNOSTICA STAGO, INC.
STA-QUALITY HBPM/LMWH KIT
2001-04-09
DIAGNOSTICA STAGO, INC.
STA -CALIBRATOR HBPM/LMWH KIT
2001-04-09
DIAGNOSTICA STAGO, INC.
ASSERACHROM HPIA TEST KIT
2001-02-12
DIAGNOSTICA STAGO, INC.

GUDID#

STA® - Coag Control N + ABN - 00676
DIAGNOSTICA STAGO
2016-09-15
STA® - Coag Control (N + ABN) PLUS - 00677
DIAGNOSTICA STAGO
2016-09-15
STA® - System Control N + P - 00678
DIAGNOSTICA STAGO
2016-09-15
STA® - Liatest® Control N + P - 00526
DIAGNOSTICA STAGO
2016-09-15
STA® - Unicalibrator - 00675
DIAGNOSTICA STAGO
2016-09-15
Pool Norm - 01139
DIAGNOSTICA STAGO
2016-09-15
FDP Plasma - 00540
DIAGNOSTICA STAGO
2016-09-15
FDP Plasma (Latex) - 00541
DIAGNOSTICA STAGO
2016-09-15
FDP Plasma (Buffer) - 00551
DIAGNOSTICA STAGO
2016-09-15
STA® - Fibrinogen 5 - 00674
DIAGNOSTICA STAGO
2016-09-15
STA Compact Max® (with cap piercing option) - 58989
DIAGNOSTICA STAGO
2016-09-15
STA Compact Max® - 58990
DIAGNOSTICA STAGO
2016-09-15
STA R Max® - 59026
DIAGNOSTICA STAGO
2018-10-30
STA R Max® (with cap piercing option) - 59027
DIAGNOSTICA STAGO
2018-10-30
STA® - Desorb U - 00975
DIAGNOSTICA STAGO
2020-09-24
STA® - Cleaner Solution - 00973
DIAGNOSTICA STAGO
2020-09-29
STA® - Owren-Koller - 00360
DIAGNOSTICA STAGO
2018-09-24
STA Coag Expert® - V8
DIAGNOSTICA STAGO
2022-12-09
Coag.One server license - V8
DIAGNOSTICA STAGO
2022-12-09
Coag.One server license - V7
DIAGNOSTICA STAGO
2022-12-09
STA Coag Expert® - V7
DIAGNOSTICA STAGO
2022-12-09
STA® - Stachrom® Antiplasmin - 00659
DIAGNOSTICA STAGO
2016-09-15
F.S. Test - 00857
DIAGNOSTICA STAGO
2016-09-15
F.S. Test Unit - 00887
DIAGNOSTICA STAGO
2016-09-15
STA® - Cephascreen® 4 - 00308
DIAGNOSTICA STAGO
2016-09-15
STA® - Cephascreen® 10 - 00310
DIAGNOSTICA STAGO
2016-09-15
STA Satellite® - 58104
DIAGNOSTICA STAGO
2016-09-15
STA-R Evolution® Expert Series - 58978
DIAGNOSTICA STAGO
2016-09-15
STA-R Evolution® Expert Series (with cap piercing option) - 58979
DIAGNOSTICA STAGO
2016-09-15
STA R Max® (with cap piercing option) - 59010
DIAGNOSTICA STAGO
2016-09-15
STA R Max® - 59013
DIAGNOSTICA STAGO
2016-09-15
STA® - Néoplastine® CI 5 - 00605
DIAGNOSTICA STAGO
2016-09-15
Asserachrom® PF4 - 00951
DIAGNOSTICA STAGO
2016-09-15
STA® - Multi Hep Calibrator - 00348
DIAGNOSTICA STAGO
2016-09-15
STA® - Liatest® D-Di - 00515
DIAGNOSTICA STAGO
2016-09-15
STA® - Liatest® Free Protein S 6 - 00516
DIAGNOSTICA STAGO
2016-09-15
STA® - C.K. Prest® 5 - 00597
DIAGNOSTICA STAGO
2016-09-15
Staclot® LA - 00600
DIAGNOSTICA STAGO
2016-09-15
STA® - Néoplastine® CI Plus 5 - 00606
DIAGNOSTICA STAGO
2016-09-15
Asserachrom® HPIA - 00615
DIAGNOSTICA STAGO
2016-09-15

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