FDA.reportPublic FDA data

Abbott Diagnostics Scarborough, Inc.

Matched from indexed company URL: ABBOTT DIAGNOSTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12213591221359Abbott Diagnostics Scarborough, Inc.1N2026-01-0110 Southgate Rd Scarborough ME US 04074
30051285633005128563Abbott Diagnostics (Shanghai) Co., Ltd.1N2026-01-01151 LIBING ROAD Pilot Free Trade Zone Shanghai CN 201203
30158836793015883679Abbott Diagnostics Korea Inc.1N2026-01-0165, Borahagal-ro, Giheung-gu Yongin-si Gyeonggi KR 17099
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
138251497123612P940035NMP22 BladderChek TestNAH1996-07-02
3469671497123612P940035NMP22 BladderChek TestNAH1996-07-02
138251860989382K983457OSTEOMARK NTX SERUM EIAJMM1999-02-02
138251150591785K980518OSTEOMARKJMM1998-03-06
3468581137616619K960712BINAX STREP A TESTGTZ1996-03-22
138251137616619K960712BINAX STREP A TESTGTZ1996-03-22
3469671137616619K960712BINAX STREP A TESTGTZ1996-03-22
3468581391898792K934965BINAX LEGIONELLA URINARY ANTIGEN EIAMJH1994-09-20
138251391898792K934965BINAX LEGIONELLA URINARY ANTIGEN EIAMJH1994-09-20
3469671391898792K934965BINAX 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
3469671284800442K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitPGX2018-05-02
138251284800442K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitPGX2018-05-02
3469671645426278K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC2017-09-29
138251645426278K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitOCC2017-09-29
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
138251126842258K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitPSZ2017-04-10
3469671738845269K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitOCC2016-08-18
138251738845269K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitOCC2016-08-18
138251807746287K141757ALERE I STREP APGX2015-03-31
3469671442685473K141520ALERE I INFLUENZA A & BOCC2014-06-13
3469711442685473K141520ALERE I INFLUENZA A & BOCC2014-06-13
138251442685473K141520ALERE I INFLUENZA A & BOCC2014-06-13
3469671174928601K133851ALERE PBP2A SA/CONS CULTURE COLONY TESTMYI2014-09-03
138251174928601K133851ALERE 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
3469671959551379K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010MJZ2009-09-01
138251959551379K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010MJZ2009-09-01
3468581959551379K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010MJZ2009-09-01
3468581977421659K080003BINAXNOW G6PD TESTJBF2008-10-23
3469671977421659K080003BINAXNOW G6PD TESTJBF2008-10-23
138251977421659K080003BINAXNOW G6PD TESTJBF2008-10-23
3468581820242502K070522MODIFICATION 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
138251820242502K070522MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012MJH2007-03-15
138251978057587K032166BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065GQG2003-10-21
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
3469671030505614K021231NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMMW2002-07-30
138251030505614K021231NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMMW2002-07-30
3469671471684622K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTGTZ2001-11-30
138251471684622K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTGTZ2001-11-30
3468581471684622K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTGTZ2001-11-30
3469671892388452DEN180014WOUNDCHEK Bacterial StatusQFA2019-12-02
138251892388452DEN180014WOUNDCHEK 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
3469671888723560BP120037
3468581888723560BP120037
138251888723560BP120037
138251036270122
138251569387299
138251685071955
138251899406382
3469661054751680
3469661061927218
3468581080296267
3469671080296267
3468661080296267
3469661115014230
3468581140599760
3469671140599760
3469661282176100
3469671442129126
3469661552841715
3469671569387299
3469661581064942
3469671626575308
3469661639799341
3469661689934616
3469671899406382
3469661975007203
3469661985987225
3469662033451644

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

PMA#

NMP22 BladderCheck Test

2022-07-12

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 Fe...

PMN#

ACP

1999-05-19

ABBOTT DIAGNOSTICS MFG., INC.

GUDID#

Alere Afinion™ AS100 - Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of care testing, designed to analyze the Afinion Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion Analyzer to a laboratory information system or another electronic journal system. Alere Afinion AS100 Analyzer System, consisting of Alere Afinion AS100 Analyzer with Alere Afinion Data ConnectivityConverter (ADCC), Afinion Test Cartridges and Afinion Controls is for in vitro diagnostic use only.Contents: 1 Alere Afinion AS100

Abbott Diagnostics Technologies AS

2023-10-26