Alere Scarborough Inc

FDA Filings

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

Alere Scarborough Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• ALERE (SHANGHAI) DIAGNOSTICS CO., LTD.
• Kristin Gordon
• SPD DEVELOPMENT COMPANY LIMITED

FDA Filings

Device Company	Device	Date
GUDID 10811877010798 Alere Scarborough, Inc.	DIGIVAL Calibration Check Card Pack	2023-09-14
GUDID 10811877010637 Alere Scarborough, Inc.	Alere NMP22® Urine Collection Kit	2023-09-14
GUDID 10811877010606 Alere Scarborough, Inc.	Alere NMP22 BladderChek Control Kit	2023-09-14
GUDID 10811877010545 Alere Scarborough, Inc.	Alere NMP22 Test	2023-09-14
GUDID 00811877011798 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2023-09-13
GUDID 00811877011507 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2023-09-13
GUDID 00811877011477 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2023-09-13
GUDID 10811877010965 Alere Scarborough, Inc.	ISOLATOR™ 10 mL Microbial Tubes	2023-09-12
GUDID 10811877010880 Alere Scarborough, Inc.	Alere Influenza A & B Control Swab Kit	2023-09-12
GUDID 10811877010866 Alere Scarborough, Inc.	Alere™ i Strep A Control Swab Kit	2023-09-12
GUDID 10811877010859 Alere Scarborough, Inc.	Alere™ i Strep A	2023-09-12
GUDID 10811877010842 Alere Scarborough, Inc.	Alere™ PBP2a SA Culture Colony Test	2023-09-12
GUDID 10811877010811 Alere Scarborough, Inc.	Alere™ i Influenza A & B Control Swab Kit	2023-09-12
GUDID 10811877010804 Alere Scarborough, Inc.	Alere™ i Influenza A & B	2023-09-12
GUDID 10811877010767 Alere Scarborough, Inc.	Binax® Legionella EIA Wash Buffer Accessory Kit	2023-09-12
GUDID 10811877010583 Alere Scarborough, Inc.	ID NOW Strep A 2 Control Swab Kit	2023-09-12
GUDID 10811877010552 Alere Scarborough, Inc.	ID NOW Strep A 2	2023-09-12
GUDID 10811877010538 Alere Scarborough, Inc.	ID NOW RSV Control Swab Kit	2023-09-12
GUDID 10811877010521 Alere Scarborough, Inc.	ID NOW RSV	2023-09-12
GUDID 10811877010491 Alere Scarborough, Inc.	Alere™ BinaxNOW® Legionella Control Swab Kit	2023-09-12
GUDID 10811877010460 Alere Scarborough, Inc.	Binax® Legionella Urinary Antigen EIA	2023-09-12
GUDID 10811877010439 Alere Scarborough, Inc.	ID NOW Influenza A & B Control Swab Kit	2023-09-12
GUDID 10811877010422 Alere Scarborough, Inc.	ID NOW Influenza A & B 2	2023-09-12
GUDID 10811877010347 Alere Scarborough, Inc.	Alere Determine™ HIV–1/2 Ag/Ab Combo Controls	2023-09-12
GUDID 10811877010200 Alere Scarborough, Inc.	Alere i Strep A 2 Control Swab Kit	2023-09-12
GUDID 10811877010194 Alere Scarborough, Inc.	Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit	2023-09-12
GUDID 10811877010132 Alere Scarborough, Inc.	Alere i RSV Control Swab Kit	2023-09-12
GUDID 10811877010118 Alere Scarborough, Inc.	Alere i RSV	2023-09-12
GUDID 10811877010040 Alere Scarborough, Inc.	Alere i Strep A 2	2023-09-12
GUDID 10811877010019 Alere Scarborough, Inc.	Alere i Influenza A & B 2	2023-09-12
GUDID 00811877011514 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2023-08-21
GUDID 00811877011118 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2023-08-21
GUDID 00811877011736 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-10-11
GUDID 00811877011729 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-10-11
GUDID 00811877011361 Alere Scarborough, Inc.	ID NOW COVID-19 2.0 Control Swab Kit	2022-09-19
GUDID 00811877011354 Alere Scarborough, Inc.	ID NOW COVID-19 2.0	2022-09-19
GUDID 00811877011552 Alere Scarborough, Inc.	NMP22 BladderChek Control Kit	2022-08-16
GUDID 00811877011538 Alere Scarborough, Inc.	NMP22 BladderChek Test	2022-08-16
GUDID 10811877011221 Alere Scarborough, Inc.	ID NOW Influenza A & B 2 Control Swab Kit	2022-08-15
GUDID 00811877011712 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-08-15
GUDID 00811877011705 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-08-15
GUDID 00811877011699 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-08-15
GUDID 00811877011682 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-08-15
GUDID 00811877011675 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-08-15
GUDID 00811877011576 Alere Scarborough, Inc.	BinaxNOW COVID-19 Reagent Accessory Kit	2022-06-27
GUDID 10811877011214 Alere Scarborough, Inc.	DIGIVAL Tray Pack 1	2022-06-10
GUDID 10811877011023 Alere Scarborough, Inc.	BinaxNOW Legionella Urinary Antigen Card	2022-06-10
GUDID 10811877011016 Alere Scarborough, Inc.	Alere Reader BinaxNOW Tray Pack	2022-06-10
GUDID 10811877010873 Alere Scarborough, Inc.	Alere Influenza A & B Test	2022-06-10
GUDID 10811877010774 Alere Scarborough, Inc.	Alere NMP22 BladderChek Test	2022-06-10
GUDID 10811877010705 Alere Scarborough, Inc.	BinaxNOW® G6PD	2022-06-10
GUDID 10811877010569 Alere Scarborough, Inc.	Alere NMP22 BladderChek Test	2022-06-10
GUDID 10811877010477 Alere Scarborough, Inc.	Alere™ BinaxNOW® Legionella Urinary Antigen Card	2022-06-10
GUDID 10811877010323 Alere Scarborough, Inc.	Alere Determine™ HIV–1/2 Ag/Ab Combo	2022-06-10
GUDID 10811877010293 Alere Scarborough, Inc.	Alere Determine™ HIV–1/2 Ag/Ab Combo	2022-06-10
GUDID 10811877010156 Alere Scarborough, Inc.	Alere BinaxNOW Influenza A & B Card 2	2022-06-10
GUDID 00811877011521 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2022-05-06
GUDID 00811877011125 Alere Scarborough, Inc.	Determine™ HIV–1/2 Ag/Ab Combo Controls	2022-01-21
GUDID 00811877011101 Alere Scarborough, Inc.	Determine™ HIV–1/2 Ag/Ab Combo	2022-01-21
GUDID 00811877010395 Alere Scarborough, Inc.	Fingerstick Sample Collection Kit	2022-01-21
PMA P940035S016 ALERE SCARBOROUGH, INC	Alere NMP22 BladderChek Test	2021-06-15
GUDID 10811877011009 Alere Scarborough, Inc.	Alere Reader Calibration Check Card	2021-05-10
GUDID 00811877011460 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2021-04-29
GUDID 00811877011453 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2021-04-29
GUDID 00811877011446 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2021-04-29
GUDID 00811877011415 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2021-04-29
GUDID 00811877011408 Alere Scarborough, Inc.	BinaxNOW COVID-19 Antigen Self Test	2021-04-29
GUDID 10811877010064 Alere Scarborough, Inc.	ISOSTAT® Consumables	2021-02-19
GUDID 10811877011337 Alere Scarborough, Inc.	BinaxNOW COVID-19 Ag Card Home Test	2021-01-05
GUDID 00811877011330 Alere Scarborough, Inc.	BinaxNOW COVID-19 Ag Card Home Test	2020-12-25
GUDID 10811877010958 Alere Scarborough, Inc.	ISOLATOR™ 1.5 mL Microbial Tubes	2020-11-02
GUDID 10811877011207 Alere Scarborough, Inc.	BinaxNOW RSV Control Swab Kit	2020-09-24
GUDID 10811877011191 Alere Scarborough, Inc.	BinaxNOW RSV	2020-09-24
GUDID 10811877011184 Alere Scarborough, Inc.	BinaxNOW RSV	2020-09-24
GUDID 10811877011177 Alere Scarborough, Inc.	BinaxNOW RSV	2020-09-24
GUDID 10811877011160 Alere Scarborough, Inc.	BinaxNOW RSV	2020-09-24
GUDID 10811877011092 Alere Scarborough, Inc.	BinaxNOW Streptococcus pneumoniae Control Swab Pack	2020-09-24
GUDID 10811877011061 Alere Scarborough, Inc.	BinaxNOW Streptococcus pneumoniae Antigen Card	2020-09-24
GUDID 10811877010941 Alere Scarborough, Inc.	Osteomark NTx Serum	2020-09-24
GUDID 10811877010934 Alere Scarborough, Inc.	Osteomark NTx Urine	2020-09-24
GUDID 10811877010927 Alere Scarborough, Inc.	BinaxNOW Strep A Card	2020-09-24
GUDID 10811877010484 Alere Scarborough, Inc.	BinaxNOW Nasopharyngeal Swab Accessory Kit	2020-09-24
GUDID 10811877010453 Alere Scarborough, Inc.	BinaxNOW Strep A Card	2020-09-24
GUDID 10811877010446 Alere Scarborough, Inc.	BinaxNOW Strep A Control Swab Pack	2020-09-24
GUDID 10811877011313 Alere Scarborough, Inc.	COVID-19 Swab Transport Accessory Pack	2020-09-04
GUDID 10811877011306 Alere Scarborough, Inc.	BinaxNOW COVID-19 Ag Positive Control Swab Pack	2020-08-10
GUDID 10811877011290 Alere Scarborough, Inc.	BinaxNOW COVID-19 Ag Card	2020-08-10
GUDID 10811877011245 Alere Scarborough, Inc.	WOUNDCHEK™ Bacterial Status	2020-06-03
GUDID 10811877011276 Alere Scarborough, Inc.	ID NOW™ COVID-19 Control Swab Kit	2020-04-20
GUDID 10811877011269 Alere Scarborough, Inc.	ID NOW™ COVID-19	2020-04-07
GUDID 10811877011238 Alere Scarborough, Inc.	Clearview PBP2a SA Culture Colony Test	2020-01-28
De Novo DEN180014 Alere Scarborough, Inc.	WOUNDCHEK Bacterial Status	2019-12-02
GUDID 10811877010712 Alere Scarborough, Inc.	BinaxNOW® Malaria Positive Control Kit	2019-10-07
GUDID 10811877010378 Alere Scarborough, Inc.	BinaxNOW® Malaria	2019-10-07
GUDID 10811877010361 Alere Scarborough, Inc.	BinaxNOW® Malaria	2019-10-07
GUDID 10811877011054 Alere Scarborough, Inc.	BinaxNOW™ Legionella Control Swab Pack	2019-07-23
GUDID 10811877010989 Alere Scarborough, Inc.	BinaxNOW Influenza A & B Card 2 Control Swab Kit	2019-07-23
GUDID 10811877010972 Alere Scarborough, Inc.	BinaxNOW Influenza A & B Card 2	2019-07-23
GUDID 00811877010623 Alere Scarborough, Inc.	DIGIVAL	2019-07-16
PMN K190204 Alere Scarborough, Inc.	ID NOW Influenza A & B 2	2019-03-18
GUDID 00811877010999 Alere Scarborough, Inc.	Alere Reader	2019-03-11
GUDID 00811877010616 Alere Scarborough, Inc.	ID NOW™ Instrument	2018-11-29
GUDID 00811877010593 Alere Scarborough, Inc.	ID NOW™ Instrument	2018-11-29
PMN K181853 Alere Scarborough, Inc.	Alere BinaxNOW Influenza A & B Card 2, Alere Reader	2018-08-08
PMA P940035S015 ALERE SCARBOROUGH, INC	Alere NMP22 BladderChek Test	2018-05-17
PMN K173653 Alere Scarborough, Inc.	Alere I Strep A 2, Alere I Instrument, Alere I Strep A 2 Control Swab Kit	2018-05-02
PMN K173932 Alere Scarborough, Inc.	Alere I Influenza A & B, Alere I Strep A, Alere I RSV, Alere I Influenza A & B 2	2018-01-26
PMN K173502 Alere Scarborough, Inc.	Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit	2017-12-13
PMN K171792 Alere Scarborough, Inc.	Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit	2017-09-29
PMN K162642 ALERE SCARBOROUGH, INC.	Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit	2017-04-10
PMA P940035S014 ALERE SCARBOROUGH, INC	MATRITECH NMP22(TM) TEST KIT	2017-02-27
PMN K163266 ALERE SCARBOROUGH, INC.	Alere I Influenza A & B, Alere I Influenza A & B Control Swab Kit, Alere I Instrument	2016-12-21
PMA P940035S013 ALERE SCARBOROUGH, INC	Alere NMP22 BladderChek Test	2016-09-08
PMN K161375 ALERE SCARBOROUGH, INC.	Alere I RSV, Alere I Instrument, Alere I RSV Control Swab Kit	2016-08-18
PMN K161364 ALERE SCARBOROUGH, INC.	BinaxNOW G6PD Test	2016-06-17
PMA P940035S012 ALERE SCARBOROUGH, INC	ALERE NMP22(TM) TEST	2016-05-06
PMN K151464 ALERE SCARBOROUGH, INC.	Alere I Influenza A & B, Alere I Instrument, Alere I Influenza A & B Control Swab Kit	2015-07-28
PMA P940035S011 ALERE SCARBOROUGH, INC	ALERE NMP22 BLADDERCHEK TEST	2015-07-28
PMN K151690 ALERE SCARBOROUGH, INC.	Alere I Instrument, Alere I Influenza A & B, Alere I Strep A	2015-07-16
PMN K141757 ALERE SCARBOROUGH, INC	ALERE I STREP A	2015-03-31
PMN K133851 ALERE SCARBOROUGH, INC	ALERE PBP2A SA/CONS CULTURE COLONY TEST	2014-09-03
PMN K141520 ALERE SCARBOROUGH, INC D/B/A BINAX, INC.	ALERE I INFLUENZA A & B	2014-06-13
PMN K123986 ALERE SCARBOROUGH, INC	ACTIM PROM	2014-01-09
PMN K133637 ALERE SCARBOROUGH, INC D/B/A BINAX, INC.	ALERE INFLUENZA A & B TEST	2013-12-18
PMN K133411 ALERE SCARBOROUGH, INC D/B/A BINAX, INC.	ALERE BINAXNOW INFLUENZA A & B CARD	2013-12-05
PMA P940035S010 ALERE SCARBOROUGH, INC	ALERE NMP22 TEST	2013-07-16
PMA P940035S009 ALERE SCARBOROUGH, INC	NMP22 BLADDERCHEK TEST	2013-04-02
PMN K121905 ALERE SCARBOROUGH, INC	ALERE PBP2A TEST	2012-07-26
PMA P940035S008 ALERE SCARBOROUGH, INC	ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT	2012-03-21
PMA P940035S007 ALERE SCARBOROUGH, INC	ALERE NMP22 URINE COLLECTION KIT	2012-01-20
PMA P940035S006 ALERE SCARBOROUGH, INC	NMP22 BLADDERCHEK TEST KIT	2011-11-15
PMN K103610 ALERE SCARBOROUGH, INC D/B/A BINAX, INC.	CLEARVIEW EXACT II INFLUENZA A & B TEST	2011-01-06
PMA P940035S005 ALERE SCARBOROUGH, INC	NMP22 ELISA TEST KIT	2008-06-03
PMA P940035S004 ALERE SCARBOROUGH, INC	NMP22 BLADDERCHEK TEST KIT	2008-05-20
PMA P940035S003 ALERE SCARBOROUGH, INC	NMP22 BLADDERCHEK TEST KIT	2003-04-25
PMA P940035S002 ALERE SCARBOROUGH, INC	MATRITECH NMP22 TEST KIT	2000-01-18
PMA P940035S001 ALERE SCARBOROUGH, INC	MATRITECH NMP22(TM) TEST KIT	1997-03-19
PMA P940035 ALERE SCARBOROUGH, INC	MATRITECH NMP22(TM) TEST KIT	1996-07-02

Related Finance Registrations

SEC

0000833652

ALERE SCARBOROUGH, INC. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091026992	Shanghai ,China (Mainland) -> Boston, Massachusetts	SILICA GEL DESICCANT	50 PKG
2020062514853	Shanghai ,China (Mainland) -> Boston, Massachusetts	SILICA GEL DESICCANT	2 PKG
2020040911703	Shanghai ,China (Mainland) -> Boston, Massachusetts	SILICA GEL DESICCANT	2 PKG
2020012323509	Shanghai ,China (Mainland) -> Boston, Massachusetts	SILICA GEL DESICCANT	2 PKG
2019112114321	Shanghai ,China (Mainland) -> Boston, Massachusetts	BUFFER BOTTLE	61 PKG
2019070843832	Haifa,Israel -> New York/Newark Area, Newark, New Jersey	WORK STATION H.S CODE 392690	90 CTN
2019060113826	Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey	POWER SUPPLY6 PALLETS 156CTNSHS CODE 8504401400	156 PKG
2019051110310	Shanghai ,China (Mainland) -> Boston, Massachusetts	SILICA GEL DESICCANT MOLECULAR SIEVE DESICCANT	56 PKG