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:

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
ALERE SCARBOROUGH, INC
Alere NMP22 BladderChek Test2021-06-15
Alere Scarborough, Inc.
Alere Reader Calibration Check Card 2021-05-10
Alere Scarborough, Inc.
BinaxNOW COVID-19 Antigen Self Test 2021-04-29
Alere Scarborough, Inc.
BinaxNOW COVID-19 Antigen Self Test 2021-04-29
Alere Scarborough, Inc.
BinaxNOW COVID-19 Antigen Self Test 2021-04-29
Alere Scarborough, Inc.
BinaxNOW COVID-19 Antigen Self Test 2021-04-29
Alere Scarborough, Inc.
BinaxNOW COVID-19 Antigen Self Test 2021-04-29
Alere Scarborough, Inc.
ISOSTAT® Consumables 2021-02-19
Alere Scarborough, Inc.
BinaxNOW COVID-19 Ag Card Home Test 2021-01-05
Alere Scarborough, Inc.
BinaxNOW COVID-19 Ag Card Home Test 2020-12-25
Alere Scarborough, Inc.
ISOLATOR™ 1.5 mL Microbial Tubes 2020-11-02
Alere Scarborough, Inc.
BinaxNOW RSV Control Swab Kit 2020-09-24
Alere Scarborough, Inc.
BinaxNOW RSV 2020-09-24
Alere Scarborough, Inc.
BinaxNOW RSV 2020-09-24
Alere Scarborough, Inc.
BinaxNOW RSV 2020-09-24
Alere Scarborough, Inc.
BinaxNOW RSV 2020-09-24
Alere Scarborough, Inc.
BinaxNOW Streptococcus pneumoniae Control Swab Pack 2020-09-24
Alere Scarborough, Inc.
BinaxNOW Streptococcus pneumoniae Antigen Card 2020-09-24
Alere Scarborough, Inc.
Osteomark NTx Serum 2020-09-24
Alere Scarborough, Inc.
Osteomark NTx Urine 2020-09-24
Alere Scarborough, Inc.
BinaxNOW Strep A Card 2020-09-24
Alere Scarborough, Inc.
BinaxNOW Nasopharyngeal Swab Accessory Kit 2020-09-24
Alere Scarborough, Inc.
BinaxNOW Strep A Card 2020-09-24
Alere Scarborough, Inc.
BinaxNOW Strep A Control Swab Pack 2020-09-24
Alere Scarborough, Inc.
COVID-19 Swab Transport Accessory Pack 2020-09-04
Alere Scarborough, Inc.
BinaxNOW COVID-19 Ag Positive Control Swab Pack 2020-08-10
Alere Scarborough, Inc.
BinaxNOW COVID-19 Ag Card 2020-08-10
Alere Scarborough, Inc.
WOUNDCHEK™ Bacterial Status 2020-06-03
Alere Scarborough, Inc.
ID NOW™ COVID-19 Control Swab Kit 2020-04-20
Alere Scarborough, Inc.
ID NOW™ COVID-19 2020-04-07
Alere Scarborough, Inc.
Clearview PBP2a SA Culture Colony Test 2020-01-28
Alere Scarborough, Inc.
WOUNDCHEK Bacterial Status2019-12-02
Alere Scarborough, Inc.
BinaxNOW® Malaria Positive Control Kit 2019-10-07
Alere Scarborough, Inc.
BinaxNOW® Malaria 2019-10-07
Alere Scarborough, Inc.
BinaxNOW® Malaria 2019-10-07
Alere Scarborough, Inc.
BinaxNOW™ Legionella Control Swab Pack 2019-07-23
Alere Scarborough, Inc.
BinaxNOW Influenza A & B Card 2 Control Swab Kit 2019-07-23
Alere Scarborough, Inc.
BinaxNOW Influenza A & B Card 2 2019-07-23
Alere Scarborough, Inc.
DIGIVAL 2019-07-16
Alere Scarborough, Inc.
ID NOW Influenza A & B 22019-03-18
Alere Scarborough, Inc.
Alere Reader 2019-03-11
Alere Scarborough, Inc.
ID NOW™ Instrument 2018-11-29
Alere Scarborough, Inc.
ID NOW™ Instrument 2018-11-29
Alere Scarborough, Inc.
Alere BinaxNOW Influenza A & B Card 2, Alere Reader2018-08-08
ALERE SCARBOROUGH, INC
Alere NMP22 BladderChek Test2018-05-17
Alere Scarborough, Inc.
Alere I Strep A 2, Alere I Instrument, Alere I Strep A 2 Control Swab Kit2018-05-02
Alere Scarborough, Inc.
Alere™ i Instrument 2018-03-29
Alere Scarborough, Inc.
Alere™ i Instrument 2018-03-29
Alere Scarborough, Inc.
ISOSTAT® Containment Adapter 2018-03-29
Alere Scarborough, Inc.
ISOSTAT® Press and Rack 2018-03-29
Alere Scarborough, Inc.
Alere I Influenza A & B, Alere I Strep A, Alere I RSV, Alere I Influenza A & B 22018-01-26
Alere Scarborough, Inc.
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit2017-12-13
Alere Scarborough, Inc.
Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit2017-09-29
ALERE SCARBOROUGH, INC.
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit2017-04-10
ALERE SCARBOROUGH, INC
MATRITECH NMP22(TM) TEST KIT2017-02-27
ALERE SCARBOROUGH, INC.
Alere I Influenza A & B, Alere I Influenza A & B Control Swab Kit, Alere I Instrument2016-12-21
ALERE SCARBOROUGH, INC
Alere NMP22 BladderChek Test2016-09-08
ALERE SCARBOROUGH, INC.
Alere I RSV, Alere I Instrument, Alere I RSV Control Swab Kit2016-08-18
ALERE SCARBOROUGH, INC.
BinaxNOW G6PD Test2016-06-17
ALERE SCARBOROUGH, INC
ALERE NMP22(TM) TEST2016-05-06
ALERE SCARBOROUGH, INC.
Alere I Influenza A & B, Alere I Instrument, Alere I Influenza A & B Control Swab Kit2015-07-28
ALERE SCARBOROUGH, INC
ALERE NMP22 BLADDERCHEK TEST2015-07-28
ALERE SCARBOROUGH, INC.
Alere I Instrument, Alere I Influenza A & B, Alere I Strep A2015-07-16
ALERE SCARBOROUGH, INC
ALERE I STREP A2015-03-31
ALERE SCARBOROUGH, INC
ALERE PBP2A SA/CONS CULTURE COLONY TEST2014-09-03
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
ALERE I INFLUENZA A & B2014-06-13
ALERE SCARBOROUGH, INC
ACTIM PROM2014-01-09
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
ALERE INFLUENZA A & B TEST2013-12-18
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
ALERE BINAXNOW INFLUENZA A & B CARD2013-12-05
ALERE SCARBOROUGH, INC
ALERE NMP22 TEST2013-07-16
ALERE SCARBOROUGH, INC
NMP22 BLADDERCHEK TEST2013-04-02
ALERE SCARBOROUGH, INC
ALERE PBP2A TEST2012-07-26
ALERE SCARBOROUGH, INC
ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT2012-03-21
ALERE SCARBOROUGH, INC
ALERE NMP22 URINE COLLECTION KIT2012-01-20
ALERE SCARBOROUGH, INC
NMP22 BLADDERCHEK TEST KIT2011-11-15
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
CLEARVIEW EXACT II INFLUENZA A & B TEST2011-01-06
ALERE SCARBOROUGH, INC
NMP22 ELISA TEST KIT2008-06-03
ALERE SCARBOROUGH, INC
NMP22 BLADDERCHEK TEST KIT2008-05-20
ALERE SCARBOROUGH, INC
NMP22 BLADDERCHEK TEST KIT2003-04-25
ALERE SCARBOROUGH, INC
MATRITECH NMP22 TEST KIT2000-01-18
ALERE SCARBOROUGH, INC
MATRITECH NMP22(TM) TEST KIT1997-03-19
ALERE SCARBOROUGH, INC
MATRITECH NMP22(TM) TEST KIT1996-07-02

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091026992Shanghai ,China (Mainland) -> Boston, MassachusettsSILICA GEL DESICCANT50 PKG
2020062514853Shanghai ,China (Mainland) -> Boston, MassachusettsSILICA GEL DESICCANT2 PKG
2020040911703Shanghai ,China (Mainland) -> Boston, MassachusettsSILICA GEL DESICCANT2 PKG
2020012323509Shanghai ,China (Mainland) -> Boston, MassachusettsSILICA GEL DESICCANT2 PKG
2019112114321Shanghai ,China (Mainland) -> Boston, MassachusettsBUFFER BOTTLE61 PKG
2019070843832Haifa,Israel -> New York/Newark Area, Newark, New JerseyWORK STATION H.S CODE 39269090 CTN
2019060113826Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyPOWER SUPPLY6 PALLETS 156CTNSHS CODE 8504401400156 PKG
2019051110310Shanghai ,China (Mainland) -> Boston, MassachusettsSILICA GEL DESICCANT MOLECULAR SIEVE DESICCANT56 PKG

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