Abbott Diagnostics Scarborough Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 1221359
• FEI Number: 1221359
• Name: ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• Owner & Operator: Abbott
• Contact Address: 100 Abbott Park Building J49; Abbott Park IL 60064 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10 Southgate Rd ; Scarborough, ME 04074 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K220801 Abbott Diagnostics Scarborough, Inc.	ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2	2022-06-24
QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW COVID-19	2020-03-30
PMN DEN180014 | QFA ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	WOUNDCHEK Bacterial Status	2020-01-10
PMN DEN180014 | QFA ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	WOUNDCHEK Bacterial Status Control Kit	2020-01-10
PMN K191534 Abbott Diagnostics Scarborough, Inc.	ID NOW Influenza A & B 2	2019-07-11
PMN K173653 | PGX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Strep A 2	2018-05-10
PMN K173653 | PGX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2018-05-10
PMN K173653 | PGX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2018-05-10
PMN K173653 | PGX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Strep A 2	2018-05-10
PMN K173653 | PGX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2018-05-10
PMN K173653 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Strep A 2	2018-05-10
PMN K173653 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2018-05-10
PMN K173653 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2018-05-10
PMN K173653 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Strep A 2	2018-05-10
PMN K173653 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2018-05-10
PMN K171792 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2017-11-06
PMN K171792 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2017-11-06
PMN K171792 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Influenza A & B 2	2017-11-06
PMN K171792 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2017-11-06
PMN K171792 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Influenza A & B 2	2017-11-06
PMN K171792 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2017-11-06
PMN K171792 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2017-11-06
PMN K171792 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Influenza A & B 2	2017-11-06
PMN K171792 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2017-11-06
PMN K171792 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Influenza A & B 2	2017-11-06
PMN K171792 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2017-11-06
PMN K171792 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2017-11-06
PMN K171792 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Influenza A & B 2	2017-11-06
PMN K171792 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2017-11-06
PMN K171792 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Influenza A & B 2	2017-11-06
PMN K162642 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	DIGIVAL	2017-08-01
PMN K162642 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Influenza A & B Card 2	2017-08-01
PMN K162642 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere Reader	2017-08-01
PMN K162642 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere BinaxNOW Influenza A & B Card 2	2017-08-01
PMN K161375 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? RSV	2016-09-20
PMN K161375 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2016-09-20
PMN K161375 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2016-09-20
PMN K161375 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i RSV	2016-09-20
PMN K161375 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2016-09-20
PMN K161375 | OEM ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? RSV	2016-09-20
PMN K161375 | OEM ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2016-09-20
PMN K161375 | OEM ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2016-09-20
PMN K161375 | OEM ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i RSV	2016-09-20
PMN K161375 | OEM ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2016-09-20
PMN K161375 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? RSV	2016-09-20
PMN K161375 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Molecular System	2016-09-20
PMN K161375 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2016-09-20
PMN K161375 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i RSV	2016-09-20
PMN K161375 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2016-09-20
PMN K141757 | PGX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Strep A	2015-04-22
PMN K141757 | PGX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2015-04-22
PMN K141757 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Strep A	2015-04-22
PMN K141757 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2015-04-22
PMN K133851 | MYI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	CLEARVIEW PBP2a SA Culture Colony Test	2015-04-22
PMN K133851 | MYI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere PBP2a SA Culture Colony Test	2015-04-22
PMN K133637 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Clearview Exact II Influenza A & B Test	2014-10-16
PMN K133637 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere Influenza A & B Test	2014-10-16
PMN K141520 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2014-06-27
PMN K141520 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2014-06-27
PMN K141520 | OZE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Influenza A&B	2014-06-27
PMN K141520 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2014-06-27
PMN K141520 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2014-06-27
PMN K141520 | OOI ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Influenza A&B	2014-06-27
PMN K141520 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	ID NOW? Instrument	2014-06-27
PMN K141520 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Instrument	2014-06-27
PMN K141520 | OCC ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere i Influenza A&B	2014-06-27
PMN BP120037 | MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere Determine HIV-1/2 Ag/Ab Combo	2013-09-10
PMN BP120037 | MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere Determine HIV-1/2 Ag/Ab Combo Controls	2013-09-10
JBE ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Systagenix Woundchek Protease Status	2012-02-03
PMN K103610 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Clearview Exact II Influenza A & B Test	2011-12-22
PMN K103610 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere Influenza A & B Test	2011-12-22
PMN K832246 | LIO ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Isolator 1.5 Microbial Tube (Ped)	2010-03-10
PMN K810664 | JKA ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Isolator 10 ml Microbial Tube-Adult	2010-03-10
PMN K092223 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Influenza A&B Test	2010-01-08
PMN K092223 | PSZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere BinaxNOW Influenza A & B Card	2010-01-08
PMN K083744 | MJZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Malaria Positive Control	2010-01-08
PMN K983457 | JMM ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Osteomark NTx Serum ELISA	2009-09-08
PMN K980518 | JMM ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Osteomark NTx Urine ELISA	2009-08-19
LIB ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Determine TB LAM Ag	2008-12-03
LIB ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Bioline Filariasis Test Strip	2008-12-03
LIB ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Filariasis	2008-12-03
LIB ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere Filariasis Test Strip	2008-12-03
LIB ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere Determine TB LAM Ag	2008-12-03
PMN K080003 | JBF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNow G6PD Test	2008-12-02
PMN K070522 | MJH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Legionella Urinary Antigen Test	2008-12-02
PMN K070522 | MJH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Legionella Urinary Antigen Card	2008-12-02
PMN K070522 | MJH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere BinaxNOW Legionlla Urinary Antigen Card	2008-12-02
OJO ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Clearview TB ELISA LAM Antigen Test	2008-08-18
PMN P940035 | NAH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	NMP22 Urine Collection Kit	2008-01-17
PMN P940035 | NAH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	NMP22 Test	2008-01-17
PMN P940035 | NAH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	NMP22 BladderChek Test	2008-01-17
PMN P940035 | NAH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Matritech NMP22 ELISA Test Kit	2008-01-17
PMN P940035 | NAH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Matritech NMP22 Bladdercheck Test	2008-01-17
PMN P940035 | NAH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere NMP22 Test Kit	2008-01-17
PMN P940035 | NAH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere NMP22 BladderChek Test	2008-01-17
PMN K021231 | MMW ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	NMP22 BladderChek Control Kit	2008-01-17
PMN K021231 | MMW ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Matritech NMP22 BladderChek Control Kit	2008-01-17
PMN K021231 | MMW ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere NMP22 BladderChek Control Kit	2008-01-17
PMN K960712 | GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNow Strep A Test	2007-12-05
PMN K960712 | GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere BinaxNOW Strep A Card	2007-12-05
PMN K934965 | MJH ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Legionella Urinary Antigen Enzyme Immunoassay Kit	2007-12-05
PMN K032166 | GQG ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW RSV Test	2007-12-05
PMN K032166 | GQG ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW RSV Card	2007-12-05
PMN K032166 | GQG ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere BinaxNOW RSV Card	2007-12-05
PMN K012521 | GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Streptococcus pneumoniae Test	2007-12-05
PMN K012521 | GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNOW Streptococcus pneumoniae Antigen Card	2007-12-05
PMN K012521 | GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Alere BinaxNOW Streptococcus pneumoniae Antigen Card	2007-12-05
PMN DEN070006 | OAX ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	BinaxNow Malaria Test	2007-12-05
PMN K840496 | JKA ABBOTT DIAGNOSTICS SCARBOROUGH, INC. [Abbott]	Isostat Microbial Tube Proc. System	2007-11-19

Similar & Related FDA Registered Companies

• Abbott Diagnostics Scarborough, Inc.10 Southgate Roadscarborough, ME 04074 PMA NumberP940035 Supplement NumberS017 Date Received02/08/2022 Decision Date07/12/2022 Product Code NAH  Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091856719	Bremerhaven,Federal Republic of Germany -> Boston, Massachusetts	300 CTNS POWER SUPPLY MODEL NO.:KSA-42W-120350D5 PO NO.: 67835 WO:JSO1-2005060001 H.S. CODE # 8504401400	300 CTN
2019082638168	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	WORK STATION H.S CODE 392690	90 CTN
2019081319268	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	WORK STATION H.S CODE 392690 .	90 CTN