ABBOTT LABORATORIES

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1415939	1415939	ABBOTT LABORATORIES	1	N	2026-01-01	100 ABBOTT PARK RD. Abbott Park IL US 60064
1451914	1451914	ABBOTT LABORATORIES	1	Y	2026-01-01	U.S. 41/MARTIN LUTHER KING DR. North Chicago IL US 60064
1628664	1628664	ABBOTT LABORATORIES	1	N	2026-01-01	1921 Hurd Dr IRVING TX US 75038
2630031	2630031	ABBOTT LABORATORIES (PUERTO RICO) INCORPORATED	1	Y	2026-01-01	9615 Ave Los Romeros Ste 700 San Juan PR US 00926
2919069	2919069	ABBOTT LABORATORIES	1	N	2026-01-01	647 Almanor Ave. Sunnyvale CA US 94085
3005333358	3005333358	ABBOTT LABORATORIES	1	N	2026-01-01	Conway Park 675 North Field Drive Lake Forest IL US 60045
3006412379	3006412379	Abbott Laboratories (Singapore) Private Limited	1	N	2026-01-01	3 Fraser Street #23-28 DUO Tower - Central Singapore SG 189352
3016438761	3016438761	ABBOTT LABORATORIES	1	Y	2026-01-01	1915 Hurd Drive Irving TX US 75038

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
233388	1185492289	P980007	AXSYM FREE PSA	MTG	2004-02-05
233388	1256468909	P910007	AXSYM TOTAL PSA & ARCHITECT TOTAL PSA	MTF	1991-09-25
233388	1513741180	P210003	ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit	LOM	2022-08-10
233388	1316120706	P120008	ABBOTT ARCHITECT AFP ASSAY	LOK	2012-11-28
233388	1238379979	P110029	ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS	LOM	2012-04-12
233388	1571913282	P080023	ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS	LOM	2009-04-10
233388	1203759096	P060035	ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS	LOM	2007-11-06
233388	1697919650	P050051	ABBOTT ARCHITECT AUSAB	LOM	2006-06-01
233388	1457975421	P050042	ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL	MZO	2006-06-07
2087	1470727330	K991605	CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION	GKZ	1999-07-09
236886	1946736143	K991010	ACP	CKB	1999-05-19
233388	1946736143	K991010	ACP	CKB	1999-05-19
233388	1059413930	K990774	ABBOTT ARCHITECT CEA	DHX	1999-05-11
233388	1919928846	K984437	QUANTEX ASO-CRP-RP CONTROL II	JJT	1999-02-02
233388	1757070345	K983759	ABBOTT ARCHITECT FERRITIN	DBF	1998-12-07
233388	1128228408	K983442	ABBOTT ARCHITECT TSH	JLW	1998-11-20
233388	1632719028	K983441	C3	CZW	1998-11-04
236886	1632719028	K983441	C3	CZW	1998-11-04
233388	1596630445	K983440	ABBOTT ARCHITECT TOTAL T4	KLI	1998-11-25
233388	1138439833	K983439	ABBOTT ARCHITECT FREE T3	CDP	1998-11-20
233388	1066930130	K983434	ABBOTT ARCHITECT TOTAL T3	CDP	1998-11-20
233388	1446967412	K983424	ABBOTT ARCHEITECT TOTAL B-HCG	DHA	1998-12-01
233388	1971712753	K983359	IGA	CZP	1998-11-04
236886	1971712753	K983359	IGA	CZP	1998-11-04
236886	1491571274	K983356	C4	DBI	1998-11-04
233388	1491571274	K983356	C4	DBI	1998-11-04
236886	2049809977	K983289	APOLIPOPROTEIN A1	DER	1999-01-29
233388	2049809977	K983289	APOLIPOPROTEIN A1	DER	1999-01-29
236886	1571696246	K983281	APOB	DFC	1999-01-26
233388	1571696246	K983281	APOB	DFC	1999-01-26
233388	1367077156	K983268	MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY	LFH	1998-11-18
233388	1263096791	K983221	IGG	DEW	1998-11-04
236886	1263096791	K983221	IGG	DEW	1998-11-04
233388	1361119208	K983167	TRF	DDG	1998-11-04
236886	1361119208	K983167	TRF	DDG	1998-11-04
233388	1420045196	K983159	DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS	DKB	1998-11-05
233388	1277809958	K983132	IGM	DFT	1998-11-04
236886	1277809958	K983132	IGM	DFT	1998-11-04
233388	2032722461	K983131	AST	CIT	1998-09-28
236886	2032722461	K983131	AST	CIT	1998-09-28
233388	2054123542	K983070	CK	CGS	1999-02-16
236886	2054123542	K983070	CK	CGS	1999-02-16
233388	2024701941	K981918	UREA	CDQ	1998-07-28
236886	2024701941	K981918	UREA	CDQ	1998-07-28
233388	1456062778	K981814	ALBP	CJW	1998-07-22
236886	1456062778	K981814	ALBP	CJW	1998-07-22
233388	1987538662	K981791	MG	JGJ	1998-10-23
236886	1987538662	K981791	MG	JGJ	1998-10-23
233388	1698079165	K981759	PHOS	CEO	1998-06-16
236886	1698079165	K981759	PHOS	CEO	1998-06-16
236886	1498300620	K981758	ALBG	CIX	1998-06-12
233388	1498300620	K981758	ALBG	CIX	1998-06-12
233388	1893827866	K981706	AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2	JIX	1998-07-09
236886	1893827866	K981706	AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2	JIX	1998-07-09
236886	1295441304	K981682	UPRO	JGQ	1998-09-21
233388	1295441304	K981682	UPRO	JGQ	1998-09-21
233388	1334989490	K981653	AMY	JFJ	1998-08-28
236886	1334989490	K981653	AMY	JFJ	1998-08-28
236886	1015366450	K981652	CHOL	CHH	1998-06-29
233388	1015366450	K981652	CHOL	CHH	1998-06-29
2087	1331970531	K981342	ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY	GKZ	1998-06-29
233388	1331970531	K981342	ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY	GKZ	1998-06-29
236886	1932726554	K980367	AEROSET SYSTEM	CGZ	1998-04-01
233388	1932726554	K980367	AEROSET SYSTEM	CGZ	1998-04-01
233388	1975002068	K972526	METHADONE EIA ASSAY	DJR	1997-08-04
233388	1775889558	K971777	QUANTEX ASO-CRP-RF CONTROL	JJT	1997-05-27
233388	1233385708	K971573	N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET	LBR	1997-06-18
233388	2056020146	K961393	TRICYCLICS SERUM TOX ASSAY	LFH	1996-06-12
233388	1225407426	K961372	SERUM TOX CALIBRATOR	DKB	1996-05-01
233388	1506287481	K960708	BENZODIAZEPINE SERUM TOX EIA TEST	JXM	1996-05-20
233388	2017668346	K960664	BARBITURATE SERUM TOX EIA ASSAY	DIS	1996-05-06
233388	2015631111	K960187	COCAINE METABOLITE EIA TEST	DIO	1996-04-02
233388	1643046727	K955928	BARBITURATE EIA ESSAY (MODIFICATION)	DIS	1996-03-11
233388	2063645011	K953971	TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY	CDT	1996-04-05
233388	1128814055	K952596	THEOPHYLLINE ENZYME IMMUNOASSAY	KLS	1995-08-11
233388	1050969913	K945725	PHENYTION EIA TEST	DIP	1995-02-03
233388	1254341894	K943998	CANNABINOID EIA ASSAY	LDJ	1994-11-04
233388	1131783266	K943414	PROPOXPHENE EIA TEST	JXN	1994-09-09
233388	1994459409	K940935	URINE CALIBRATOR	DKB	1994-07-06
233388	1224613904	K935320	PHENCYCLIDINE EIA ASSAY	LCM	1993-12-29
233388	1218803758	K934891	AMPHETAMINES EIA ASSAY MODIFICATION	DKZ	1994-01-13
233388	1168262186	K934667	METHADONE ENZYME IMMUNOASSAY	DJR	1994-01-26
233388	1551408659	K932113	CANNABINOID URINE CONTROLS	JJX	1993-06-29
233388	1938498396	K930529	BENZODIAZEPINE ENZYME IMMUNOASSAY	JXM	1993-08-05
233388	2043452600	K924733	ETHYL ALCOHOL CALIBRATORS & CONTROL	DNN	1992-12-09
233388	2049127414	K923783	ETHYL ALCOHOL ASSAY	DMT	1993-01-21
233388	1331461268	K923386	THC URINE CALIBRATORS	DLJ	1992-09-14
233388	1426539331	K903101	INNOFLUOR (TM) AMIKACIN CALIBRATOR SET	DLJ	1990-08-22
2087	1571043282	K901875	PARA 12 PLUS	JCN	1990-05-30
233388	1571043282	K901875	PARA 12 PLUS	JCN	1990-05-30
233388	2057235950	K894486	QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)	GTQ	1989-10-24
233388	1918620013	K892212	INNOFLUOR(TM) QUINDINE CALIBATOR SET	DLJ	1989-06-09
233388	1894489964	K872349	INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET	DLJ	1987-07-21
233388	1567794589	K840261	CAL-CHEX, A HEMATOLOGY CALIBRATOR	KRZ	1984-02-21
2087	1567794589	K840261	CAL-CHEX, A HEMATOLOGY CALIBRATOR	KRZ	1984-02-21
2087	1821768400	K823498	PARA 12	GLQ	1982-12-28
233388	1821768400	K823498	PARA 12	GLQ	1982-12-28
233388	1110591424	K243575	ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls	MYF	2025-02-12
233388	1309798336	K243500	ARCHITECT iGentamicin	LCD	2025-07-09
2087	1095503250	K243283	Alinity h-series System	GKZ	2025-02-20
191533	1095503250	K243283	Alinity h-series System	GKZ	2025-02-20
233388	1095503250	K243283	Alinity h-series System	GKZ	2025-02-20
236886	1095503250	K243283	Alinity h-series System	GKZ	2025-02-20
233388	1502685312	K243168	Alinity i Rubella IgG	LFX	2025-06-20
233388	1926482337	K242585	Cystatin C	NDY	2025-05-16
233388	1116478964	K233932	Alinity i Toxo IgM	LGD	2024-08-30
233388	1550578796	K233541	ARCHITECT Active-B12 (Holotranscobalamin)	CDD	2024-07-31
233388	1378319410	K232669	TBI	QAT	2023-09-29
233388	1029065345	K231020	Alinity c Tricyclic Antidepressants Reagent Kit	LFH	2023-11-17
233388	1479988809	K230994	Alinity i STAT High Sensitivity Troponin-I	MMI	2023-05-04
233388	1347155115	K230937	Alinity i Total ß-hCG Reagent Kit, GLP systems Track	DHA	2023-06-05
236886	1729677734	K230790	Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series	DHA	2023-05-19
233388	1729677734	K230790	Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series	DHA	2023-05-19
233388	1124229904	K223602	Traumatic brain injury (TBI) test	QAT	2023-03-02
233388	1409163087	K223324	Total Bilirubin2	CIG	2022-12-29
233388	1102197463	K223317	Alkaline Phosphatase2	CJE	2023-07-21
233388	1823985665	K222850	HAVAb IgG II	LOL	2023-08-10
233388	1574018327	K220949	Architect CMV IgG	LFZ	2022-10-27
236886	1353985901	K220031	Alinity h-series System	GKZ	2023-08-04
2087	1353985901	K220031	Alinity h-series System	GKZ	2023-08-04

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
GKZ	31	2025-02-20
DHA	8	2023-06-05
JIT	8	2017-02-15
JIX	8	2013-01-14
CIG	7	2022-12-29
GLQ	7	2011-12-22
JJY	6	2017-03-31
CFR	5	2017-10-19
JJX	5	2016-10-26
CDZ	5	2015-12-17
KRX	5	2011-12-22
DLJ	5	2001-08-27
MMI	4	2023-05-04
JGJ	4	2018-09-12
CGZ	4	2017-10-24
PDJ	4	2015-05-22
LOM	4	2012-04-12
CIT	4	2008-03-19
LCD	3	2025-07-09
CDD	3	2024-07-31
LFH	3	2023-11-17
LOL	3	2023-08-10
CJE	3	2023-07-21
CHH	3	2022-06-30
JFJ	3	2022-05-26
CGX	3	2022-03-22
CJW	3	2022-03-18
CIX	3	2021-11-23
JXM	3	2018-02-21
DIF	3	2013-09-20
LEH	3	2013-08-29
DKZ	3	2010-05-12
DFC	3	2005-04-26
DKB	3	1998-11-05
LGD	2	2024-08-30
QAT	2	2023-09-29
DGC	2	2023-02-21
LDP	2	2022-02-18
DCK	2	2019-11-08
DIO	2	2018-07-06

PMA

ARCHITECT Total PSA / Alinity i Total PSA

2023-01-27

Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS059 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufactur...

ARCHITECT CORE-M / Alinity i Anti-HBc IgM

2023-01-27

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS037 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process...

ARCHITECT AFP / Alinity i AFP

2023-01-27

Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS021 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Pr...

ARCHITECT CORE / Alinity i Anti-HBc

2023-01-27

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS039 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...

ARCHITECT Free PSA / Alinity i Free PSA

2023-01-27

Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS048 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Cha...

ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf

2023-01-27

Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS041 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Pro...

ARCHITECT AUSAB / Alinity i Anti-HBs

2023-01-27

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS049 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

ARCHITECT HBsAg Next Qualitative / Next Confirmatory

2023-01-27

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS005 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process...

ARCHITECT HBsAg Qualitative/Confirmatory/Alinity HBsAg Qualitative II/Confirmatory

2022-12-07

Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS040 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Sup...

ARCHITECT HBsAg Next Qualitative/Next Confirmatory

2022-12-07

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT AUSAB/Alinity i Anti-HBs

2022-12-07

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS048 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

Alinity i Anti-HBc (List Number 07P84)

2022-10-25

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS038 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement R...

Alinity i Anti-HBc IgM (List Number 07P86)

2022-10-25

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS036 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT AFP / Alinity i AFP

2022-10-12

Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS020 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Pr...

ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory

2022-10-12

Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS039 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Sup...

ARCHITECT AUSAB / Alinity i Anti-HBs

2022-10-12

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory

2022-10-12

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS002 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT CORE / Alinity i Anti-HBc

2022-10-12

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS037 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement R...

ARCHITECT CORE-M / Alinity i Anti-HBc IgM

2022-10-12

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS035 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT Free PSA / Alinity i Free PSA

2022-10-12

Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTG Advisory Committee Immunology Supplement Type30-day Notice Supplement ...

ARCHITECT Total PSA / Alinity i Total PSA

2022-10-12

Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS058 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process C...

ARCHITECT AUSAB / Alinity i Anti-HBs

2022-09-30

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS046 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

ARCHITECT HBsAg Qualitative/Confirmatory/Alinity i HBsAg Qualitative II/Confirmatory

2022-09-30

Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS038 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Sup...

ARCHITECT HBsAg Next Qualitative/ Next Confirmatory

2022-09-30

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS001 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit

2022-08-10

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Date Received02/08/2021 Decision Date08/10/2022 Product Code LOM Advisory Committee Microbiology Expedited Review Granted? No

ARCHITECT HBsAg Qualitative/Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory

2022-08-10

Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS037 Date Received07/18/2022 Decision Date08/10/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Sup...

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ABBOTT LABORATORIES

FDA Registration(s)

Registered Device Listings

Product Codes Associated With Registrations

PMA

PMN

GUDID