ALERE SCARBOROUGH, INC

PMA#

• Alere NMP22 BladderChek Test

  2021-06-15

  ALERE SCARBOROUGH, INC

• Alere NMP22 BladderChek Test

  2018-05-17

  ALERE SCARBOROUGH, INC

• MATRITECH NMP22(TM) TEST KIT

  2017-02-27

  ALERE SCARBOROUGH, INC

• Alere NMP22 BladderChek Test

  2016-09-08

  ALERE SCARBOROUGH, INC

• ALERE NMP22(TM) TEST

  2016-05-06

  ALERE SCARBOROUGH, INC

• ALERE NMP22 BLADDERCHEK TEST

  2015-07-28

  ALERE SCARBOROUGH, INC

• ALERE NMP22 TEST

  2013-07-16

  ALERE SCARBOROUGH, INC

• NMP22 BLADDERCHEK TEST

  2013-04-02

  ALERE SCARBOROUGH, INC

• ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

  2012-03-21

  ALERE SCARBOROUGH, INC

• ALERE NMP22 URINE COLLECTION KIT

  2012-01-20

  ALERE SCARBOROUGH, INC

• NMP22 BLADDERCHEK TEST KIT

  2011-11-15

  ALERE SCARBOROUGH, INC

• NMP22 ELISA TEST KIT

  2008-06-03

  ALERE SCARBOROUGH, INC

• NMP22 BLADDERCHEK TEST KIT

  2008-05-20

  ALERE SCARBOROUGH, INC

• NMP22 BLADDERCHEK TEST KIT

  2003-04-25

  ALERE SCARBOROUGH, INC

• MATRITECH NMP22 TEST KIT

  2000-01-18

  ALERE SCARBOROUGH, INC

• MATRITECH NMP22(TM) TEST KIT

  1997-03-19

  ALERE SCARBOROUGH, INC

• MATRITECH NMP22(TM) TEST KIT

  1996-07-02

  ALERE SCARBOROUGH, INC

PMN#

• ID NOW Influenza A & B 2

  2019-03-18

  Alere Scarborough, Inc.

• Alere BinaxNOW Influenza A & B Card 2, Alere Reader

  2018-08-08

  Alere Scarborough, Inc.

• Alere I Strep A 2, Alere I Instrument, Alere I Strep A 2 Control Swab Kit

  2018-05-02

  Alere Scarborough, Inc.

• Alere I Influenza A & B, Alere I Strep A, Alere I RSV, Alere I Influenza A & B 2

  2018-01-26

  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

  Alere Scarborough, Inc.

• Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit

  2017-09-29

  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

  ALERE SCARBOROUGH, INC.

• Alere I Influenza A & B, Alere I Influenza A & B Control Swab Kit, Alere I Instrument

  2016-12-21

  ALERE SCARBOROUGH, INC.

• Alere I RSV, Alere I Instrument, Alere I RSV Control Swab Kit

  2016-08-18

  ALERE SCARBOROUGH, INC.

• BinaxNOW G6PD Test

  2016-06-17

  ALERE SCARBOROUGH, INC.

• Alere I Influenza A & B, Alere I Instrument, Alere I Influenza A & B Control Swab Kit

  2015-07-28

  ALERE SCARBOROUGH, INC.

• Alere I Instrument, Alere I Influenza A & B, Alere I Strep A

  2015-07-16

  ALERE SCARBOROUGH, INC.

• ALERE I STREP A

  2015-03-31

  ALERE SCARBOROUGH, INC

• ALERE PBP2A SA/CONS CULTURE COLONY TEST

  2014-09-03

  ALERE SCARBOROUGH, INC

• ALERE I INFLUENZA A & B

  2014-06-13

  ALERE SCARBOROUGH, INC D/B/A BINAX, INC.

• ACTIM PROM

  2014-01-09

  ALERE SCARBOROUGH, INC

• ALERE INFLUENZA A & B TEST

  2013-12-18

  ALERE SCARBOROUGH, INC D/B/A BINAX, INC.

• ALERE BINAXNOW INFLUENZA A & B CARD

  2013-12-05

  ALERE SCARBOROUGH, INC D/B/A BINAX, INC.

• ALERE PBP2A TEST

  2012-07-26

  ALERE SCARBOROUGH, INC

• CLEARVIEW EXACT II INFLUENZA A & B TEST

  2011-01-06

  ALERE SCARBOROUGH, INC D/B/A BINAX, INC.

GUDID#

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-08-14

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-08-14

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-08-14

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-08-14

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-08-14

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-08-14

• ISOSTAT® Consumables - Consumables needed for processing ISOLATOR 10 mL Microbial Tubes for adults.

  Alere Scarborough, Inc.

  2016-09-05

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-05-06

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2026-05-06

• WOUNDCHEK™ Bacterial Status - Intended for the assessment of bacterial protease activity in chronic wounds.

  Alere Scarborough, Inc.

  2020-05-26

• ID NOW Instrument - The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.

  Alere Scarborough, Inc.

  2025-08-01

• BinaxNOW COVID-19 Antigen Self Test - A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.

  Alere Scarborough, Inc.

  2023-09-05

• BinaxNOW COVID-19 Antigen Self Test - A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.

  Alere Scarborough, Inc.

  2023-08-11

• BinaxNOW COVID-19 Antigen Self Test - A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.

  Alere Scarborough, Inc.

  2022-10-03

• BinaxNOW COVID-19 Antigen Self Test - A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.

  Alere Scarborough, Inc.

  2021-04-21

• Osteomark NTx Urine - An enzyme-linked immunosorbent assay (EIA) for the measurement of cross-linked N-telopeptides of Type I Collagen (NTx) in human urine.

  Alere Scarborough, Inc.

  2020-09-16

• Osteomark NTx Serum - A test for the quantitative measure of cross-linked N-telopeptides of Type I Collagen (NTx) in human serum as an indicator of bone resorption.

  Alere Scarborough, Inc.

  2020-09-16

• ISOSTAT® Press and Rack - ISOSTAT® Press and Rack for the processing of ISOLATOR Microbial Tubes for adults.

  Alere Scarborough, Inc.

  2016-09-05

• ISOSTAT® Containment Adapter - Adapter needed for processing ISOLATOR 10 mL Microbial Tubes for Adults

  Alere Scarborough, Inc.

  2016-09-03

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Controls - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens - display

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens - display

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens - display

  Alere Scarborough, Inc.

  2025-01-30

• BinaxNOW COVID-19/Flu A&B Combo Self Test - Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens - display

  Alere Scarborough, Inc.

  2025-01-30

• ISOLATOR™ 10 mL Microbial Tubes - The ISOLATOR™ 10 mL Microbial Tubes is intended for use in the collection and concentration of mircroorganisms from the blood.

  Alere Scarborough, Inc.

  2016-09-05

• ISOLATOR™ 1.5 mL Microbial Tubes - The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.

  Alere Scarborough, Inc.

  2020-10-23

• ID NOW™ COVID-19 Control Swab Kit - Control Swabs intended for use only with the ID NOW™ COVID-19 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs

  Alere Scarborough, Inc.

  2020-03-30

• Fingerstick Sample Collection Kit - Kit Intended to facilitate fingerstick whole blood sampling.

  Alere Scarborough, Inc.

  2022-01-13

• Alere NMP22 BladderChek Test - The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.

  Alere Scarborough, Inc.

  2014-09-01

• Alere NMP22 BladderChek Control Kit - The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the Alere NMP22 BladderChek Test.

  Alere Scarborough, Inc.

  2014-09-01

• Alere Determine™ HIV–1/2 Ag/Ab Combo Controls - The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.

  Alere Scarborough, Inc.

  2017-05-11

• Alere NMP22 Test - For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).

  Alere Scarborough, Inc.

  2014-09-01

• NMP22 BladderChek Test - NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.

  Alere Scarborough, Inc.

  2022-08-08

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