Alere Scarborough, Inc

FDA Filings

This page includes the latest FDA filings for Alere Scarborough, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Alere Scarborough, Inc.
ID NOW Influenza A & B 22019-03-18
Alere Scarborough, Inc.
Alere BinaxNOW Influenza A & B Card 2, Alere Reader2018-08-08
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 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.
Alere I Influenza A & B, Alere I Influenza A & B Control Swab Kit, Alere I Instrument2016-12-21
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 I Influenza A & B, Alere I Instrument, Alere I Influenza A & B Control Swab Kit2015-07-28
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 PBP2A TEST2012-07-26
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
CLEARVIEW EXACT II INFLUENZA A & B TEST2011-01-06

Latest Premarket Applications

PMAManufacturerDevice NameDate
ALERE SCARBOROUGH, INC
Alere NMP22 BladderChek Test2018-05-17
ALERE SCARBOROUGH, INC
MATRITECH NMP22(TM) TEST KIT2017-02-27
ALERE SCARBOROUGH, INC
Alere NMP22 BladderChek Test2016-09-08
ALERE SCARBOROUGH, INC
ALERE NMP22(TM) TEST2016-05-06
ALERE SCARBOROUGH, INC
ALERE NMP22 BLADDERCHEK TEST2015-07-28
ALERE SCARBOROUGH, INC
ALERE NMP22 TEST2013-07-16
ALERE SCARBOROUGH, INC
NMP22 BLADDERCHEK TEST2013-04-02
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
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

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Alere Scarborough, Inc.
WOUNDCHEK Bacterial Status2019-12-02

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Clearview PBP2a SA Culture Colony Test
Alere Scarborough, Inc.2020-01-28
BinaxNOW® Malaria Positive Control Kit
Alere Scarborough, Inc.2019-10-07
BinaxNOW® Malaria
Alere Scarborough, Inc.2019-10-07
BinaxNOW® Malaria
Alere Scarborough, Inc.2019-10-07
BinaxNOW™ Legionella Control Swab Pack
Alere Scarborough, Inc.2019-07-23
BinaxNOW Influenza A & B Card 2 Control Swab Kit
Alere Scarborough, Inc.2019-07-23
BinaxNOW Influenza A & B Card 2
Alere Scarborough, Inc.2019-07-23
ID NOW™ Instrument
Alere Scarborough, Inc.2018-11-29
ID NOW™ Instrument
Alere Scarborough, Inc.2018-11-29
Alere Reader
Alere Scarborough, Inc.2018-03-29
Alere™ i Instrument
Alere Scarborough, Inc.2018-03-29
Alere™ i Instrument
Alere Scarborough, Inc.2018-03-29
ISOSTAT® Containment Adapter
Alere Scarborough, Inc.2018-03-29
ISOSTAT® Press and Rack
Alere Scarborough, Inc.2018-03-29

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