ABBOTT MOLECULAR, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005248192	3005248192	ABBOTT MOLECULAR, INC.	1	Y	2026-01-01	1300 EAST TOUHY AVENUE Des Plaines IL US 60018
3009968473	3009968473	Abbott Molecular, Inc.	1	Y	2020-04-25	1800 Brummel Ave Elk Grove Village IL US 60007

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
2165	1607502001	P980024	PATHVYSION HER-2 DNA PROBE KIT	MVD	1998-12-11
2165	1111492234	P230003	Alinity m HR HPV	MAQ	2023-11-01
2165	1587924514	P210022	Alinity m CMV	PAB	2022-05-05
2165	1552575489	P200013	Alinity m HBV	MKT	2020-08-29
2165	1805965732	P190025	Alinity m HCV	MZP	2020-03-23
2165	1252645802	P170041	Abbott RealTime IDH1	OWD	2018-07-20
2165	1251071338	P170005	Abbott RealTime IDH2	OWD	2017-08-01
2165	2040089977	P160044	ABBOTT REALTIME CMV	PAB	2017-05-18
2165	1607306097	P150041	VYSIS CLL FISH PROBE KIT	PNK	2016-04-11
2165	1298217069	P120012	ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)	OBF	2013-06-20
2165	1913746976	P110012	VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK	OWE	2011-08-26
2165	1537117142	P100017	ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV	MZP	2011-05-17
2165	1691443633	P080026	ABBOTT REALTIME HBV ASSAY	MKT	2010-08-13
2165	1436424352	P030052	UROVYSION BLADDER CANCER KIT		2005-01-24
2165	1705828669	K962873	CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE	OVQ	1997-01-13
2165	1050477089	K954214	CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT	OXP	1997-01-21
2165	1951099209	K953591	CEP 8 SPECTRUMORANGE DNA PROBE KIT	OYU	1996-11-29
2165	1996107148	K243410	simpli-COLLECT STI Test	QYA	2025-01-30
2165	1491137219	K241921	Alinity m BKV	QMI	2025-03-24
2165	1941339185	K241573	Alinity m Resp-4-Plex	QOF	2025-02-14
2165	1485500074	K233349	Alinity m HSV 1 & 2 / VZV	PGI	2024-05-03
2165	1198000596	K222379	Alinity m STI Assay	QEP	2023-03-03
2165	2045324722	K212778	Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)	QLX	2022-07-15
2165	1200101773	K202977	Alinity m STI Assay	QEP	2022-04-29
2165	1349259325	K140354	ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG	LSL	2014-05-09
2165	1841823802	K140198	IMDX HSV-1/2 FOR ABBOTT M2000	OQO	2014-05-13
2165	1831209251	K131584	IMDX FLU A/B AND RSV FOR ABBOTT M2000	OCC	2013-08-21
2165	1194652361	K131508	VYSIS D7S486/CEP 7 FISH PROBE KIT	PFG	2013-09-13
2165	1584288253	K100015	VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34	OVQ	2011-08-09
2165	1681248482	K092705	ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501	OOI	2010-05-28
2165	1175598002	K091960	VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020	OWK	2011-08-29
2165	1461115465	K080739	ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT	MKZ	2008-07-10
2165	1623294705	K010288	ANEUVYSION MULITICOLOR DNA PROBE KIT	OYU	2001-04-13
2165	1611379840	DEN130010	VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)	PDO	2013-07-29
2165	1609377162	DEN040010	VYSIS AUTOVYSION SYSTEM	NTH	2004-12-13
2165	1466844139	BP200455
2165	1261225755	BP060002
2165	1830684106	BK130039
2165	1249457780
2165	1416982960
2165	1547656267
2165	1900158661
2165	1000247602
2165	1037720488
2165	1065945321
2165	1077458425
2165	1091700756
2165	1101137721
2165	1120778147
2165	1122655096
2165	1164659802
2165	1246559055
2165	1250210257
2165	1262162702
2165	1265192763
2165	1287176430
2165	1339776668
2165	1428855341
2165	1431575021
2165	1441172427
2165	1476742266
2165	1478731904
2165	1522200790
2165	1626575308
2165	1640856218
2165	1751965150
2165	1818271963
2165	1839834389
2165	1851408277
2165	1857320796
2165	1971168791
2165	2006216459
2165	2026792790
2165	2040859643
2165	2046376628
2165	2072800468

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
QEP	2	2023-03-03
OWD	2	2018-07-20
OVQ	2	2011-08-09
OYU	2	2001-04-13
QMI	1	2025-03-24
QOF	1	2025-02-14
QYA	1	2025-01-30
PGI	1	2024-05-03
QLX	1	2022-07-15
PAB	1	2022-05-05
MKT	1	2020-08-29
PAB	1	2017-05-18
PNK	1	2016-04-11
OQO	1	2014-05-13
LSL	1	2014-05-09
PFG	1	2013-09-13
OCC	1	2013-08-21
PDO	1	2013-07-29
OBF	1	2013-06-20
OWK	1	2011-08-29
OWE	1	2011-08-26
MZP	1	2011-05-17
MKT	1	2010-08-13
OOI	1	2010-05-28
MKZ	1	2008-07-10
NTH	1	2004-12-13
MVD	1	1998-12-11
OXP	1	1997-01-21

PMA#

Alinity m HBV
2021-06-01
Abbott Molecular, Inc.
Alinity m HCV
2021-06-01
Abbott Molecular, Inc.
Alinity m HBV
2021-03-08
Abbott Molecular, Inc.
Alinity m HBV
2021-03-05
Abbott Molecular, Inc.
Alinity m HCV
2021-03-05
Abbott Molecular, Inc.
Abbott RealTime HCV
2021-03-05
ABBOTT MOLECULAR, INC.
Abbott RealTime HBV
2021-03-05
ABBOTT MOLECULAR, INC.
Abbott RealTime IDH1
2021-03-03
Abbott Molecular, Inc.
Alinity m HBV
2021-01-19
Abbott Molecular, Inc.
Abbott RealTime IDH1
2021-01-19
Abbott Molecular, Inc.
Alinity m HCV
2021-01-19
Abbott Molecular, Inc.
PathVysion HER-2 DNA Probe Kit
2020-12-11
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit
2020-12-11
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit
2020-12-11
ABBOTT MOLECULAR, INC.
Abbott RealTime HCV Assay
2020-12-08
ABBOTT MOLECULAR, INC.
Abbott RealTime HBV Assay
2020-12-04
ABBOTT MOLECULAR, INC.
Alinity m HBV
2020-08-29
Abbott Molecular, Inc.
Alinity m HCV
2020-06-09
Abbott Molecular, Inc.
Vysis ALK Break Apart Fish Probe Kit
2020-05-22
ABBOTT MOLECULAR, INC.
Alinity m HCV
2020-05-06
Abbott Molecular, Inc.
Alinity m HCV
2020-03-23
Abbott Molecular, Inc.
Abbott RealTime IDH1 Assay
2019-11-12
Abbott Molecular, Inc.
RealTime IDH1
2019-09-24
Abbott Molecular, Inc.
Vysis ALK Break Apart FISH Probe Kit
2019-08-26
ABBOTT MOLECULAR, INC.
RealTime HCV
2019-05-15
ABBOTT MOLECULAR, INC.
RealTime HBV
2019-05-15
ABBOTT MOLECULAR, INC.
PathVysion HER-2 DA Probe Kit
2019-05-08
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit
2019-05-08
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit
2019-05-08
ABBOTT MOLECULAR, INC.
PathVysion HER-2 DNA Probe Kit
2018-08-29
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit
2018-08-29
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit
2018-08-29
ABBOTT MOLECULAR, INC.
Abbott RealTime IDH1
2018-07-20
Abbott Molecular, Inc.
Path Vysion HER-2 DNA Probe Kit
2018-07-11
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit
2018-07-11
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart FISH Probe Kit
2018-07-11
ABBOTT MOLECULAR, INC.
Abbott RealTime HCV Assay
2018-06-21
ABBOTT MOLECULAR, INC.
Path Vysion HER-2 DNA Probe Kit
2018-03-12
ABBOTT MOLECULAR, INC.
Vysis CLL FISH Probe Kit
2018-03-12
ABBOTT MOLECULAR, INC.
Vysis ALK Break Apart Fish Probe Kit
2018-03-12
ABBOTT MOLECULAR, INC.

114 records. Showing 1-40. Next

PMN#

Alinity m BKV
2025-03-24
Abbott Molecular, Inc.
Alinity m Resp-4-Plex
2025-02-14
Abbott Molecular, Inc.
Alinity m HSV 1 & 2 / VZV
2024-05-03
Abbott Molecular, Inc.
Alinity m STI Assay
2023-03-03
Abbott Molecular, Inc.
Alinity M EBV AMP Kit (List No. 09N43-095), Alinity M EBV CTRL Kit (List No. 09N43-085), Alinity M EBV CAL Kit (List No. 09N43-075)
2022-07-15
Abbott Molecular, Inc.
Alinity M STI Assay
2022-04-29
Abbott Molecular, Inc.
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
2014-05-09
ABBOTT MOLECULAR, INC.
VYSIS D7S486/CEP 7 FISH PROBE KIT
2013-09-13
ABBOTT MOLECULAR, INC.
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
2011-08-29
ABBOTT MOLECULAR, INC.
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
2011-08-09
ABBOTT MOLECULAR, INC.
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
2010-05-28
ABBOTT MOLECULAR, INC.
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
2010-05-28
ABBOTT MOLECULAR, INC.
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
2008-07-10
ABBOTT MOLECULAR, INC.