FDA.reportPublic FDA data

Abbott Diagnostics Scarborough, Inc.

Matched from indexed company URL: ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12213591221359Abbott Diagnostics Scarborough, Inc.1N2026-01-0110 Southgate Rd Scarborough ME US 04074
30176628533017662853Abbott Diagnostics Scarborough, Inc.1N2026-01-015 Bradley Dr Westbrook ME US 04092
30290595803029059580Abbott Diagnostics Scarborough, Inc.1N2026-01-0165 Gannett Dr Portland ME US 04106
12213591221359ABBOTT DIAGNOSTICS SCARBOROUGH, INC.1N2020-04-2510 Southgate Rd Scarborough ME US 04074

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3469671497123612P940035NMP22 BladderChek TestNAH1996-07-02
138251497123612P940035NMP22 BladderChek TestNAH1996-07-02
138251860989382K983457OSTEOMARK NTX SERUM EIAJMM1999-02-02
138251150591785K980518OSTEOMARKJMM1998-03-06
138251137616619K960712BINAX STREP A TESTGTZ1996-03-22
3469671137616619K960712BINAX STREP A TESTGTZ1996-03-22
3468581137616619K960712BINAX STREP A TESTGTZ1996-03-22
138251391898792K934965BINAX LEGIONELLA URINARY ANTIGEN EIAMJH1994-09-20
3469671391898792K934965BINAX LEGIONELLA URINARY ANTIGEN EIAMJH1994-09-20
3468581391898792K934965BINAX LEGIONELLA URINARY ANTIGEN EIAMJH1994-09-20
138251687300569K840496ISOSTAT MICROBIAL TUBE PROCESSINGJKA1984-04-13
138251885703997K832246DUPONT ISOLATOR 1.5 MICROBIAL TUBELIO1983-09-26
138251888796301K810664ISOLATOR SYSTEMJKA1981-03-31
3468581428302064K243518BinaxNOW™ COVID-19 Antigen Self TestQYT2025-02-11
3469671310021406K243262QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestSCA2025-01-13
3468581310021406K243262QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro TestSCA2025-01-13
3469671719541611K221925ID NOW COVID-19 2.0QWR2023-08-10
138251284800442K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitPGX2018-05-02
3469671284800442K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitPGX2018-05-02
138251645426278K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC2017-09-29
3469671645426278K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC2017-09-29
138251126842258K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitPSZ2017-04-10
3469671126842258K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitPSZ2017-04-10
3468581126842258K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitPSZ2017-04-10
138251738845269K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitOCC2016-08-18
3469671738845269K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitOCC2016-08-18
138251807746287K141757ALERE I STREP APGX2015-03-31
3469711442685473K141520ALERE I INFLUENZA A & BOCC2014-06-13
3469671442685473K141520ALERE I INFLUENZA A & BOCC2014-06-13
138251442685473K141520ALERE I INFLUENZA A & BOCC2014-06-13
138251174928601K133851ALERE PBP2A SA/CONS CULTURE COLONY TESTMYI2014-09-03
3469671174928601K133851ALERE PBP2A SA/CONS CULTURE COLONY TESTMYI2014-09-03
3468581174928601K133851ALERE PBP2A SA/CONS CULTURE COLONY TESTMYI2014-09-03
138251149293706K133637ALERE INFLUENZA A & B TESTPSZ2013-12-18
138251694996257K103610CLEARVIEW EXACT II INFLUENZA A & B TESTPSZ2011-01-06
138251140599760K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TESTPSZ2009-08-12
138251959551379K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010MJZ2009-09-01
3468581959551379K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010MJZ2009-09-01
3469671959551379K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010MJZ2009-09-01
138251977421659K080003BINAXNOW G6PD TESTJBF2008-10-23
3469671977421659K080003BINAXNOW G6PD TESTJBF2008-10-23
3468581977421659K080003BINAXNOW G6PD TESTJBF2008-10-23
138251820242502K070522MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012MJH2007-03-15
3469671820242502K070522MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012MJH2007-03-15
3468581820242502K070522MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012MJH2007-03-15
3468581978057587K032166BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065GQG2003-10-21
3469671978057587K032166BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065GQG2003-10-21
138251978057587K032166BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065GQG2003-10-21
138251030505614K021231NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMMW2002-07-30
3469671030505614K021231NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMMW2002-07-30
138251471684622K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTGTZ2001-11-30
3469671471684622K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTGTZ2001-11-30
3468581471684622K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTGTZ2001-11-30
138251892388452DEN180014WOUNDCHEK Bacterial StatusQFA2019-12-02
3469671892388452DEN180014WOUNDCHEK Bacterial StatusQFA2019-12-02
138251724169299DEN070006BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXXOAX2007-06-13
3468581724169299DEN070006BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXXOAX2007-06-13
3469671724169299DEN070006BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXXOAX2007-06-13
138251888723560BP120037
3469671888723560BP120037
3468581888723560BP120037
138251036270122
138251569387299
138251685071955
138251899406382
3469671080296267
3468581080296267
3469671140599760
3468581140599760
3469671442129126
3469671569387299
3469671626575308
3469671899406382

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCC72017-09-29
PSZ62017-04-10
MJH62007-03-15
GTZ62001-11-30
PGX32018-05-02
MYI32014-09-03
MJZ32009-09-01
JBF32008-10-23
OAX32007-06-13
GQG32003-10-21
SCA22025-01-13
QFA22019-12-02
MMW22002-07-30
JMM21999-02-02
NAH21996-07-02
JKA21984-04-13
QYT12025-02-11
QWR12023-08-10
LIO11983-09-26

PMN#