Medical Device Manufacturer · US , Scarborough , ME

Alere Scarborough, Inc. - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2012
17
Total
16
Cleared
1
Denied

Alere Scarborough, Inc. has 16 FDA 510(k) cleared microbiology devices. Based in Scarborough, US.

Last cleared in 2019. Active since 2012.

Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

17 devices
1–12 of 17
WOUNDCHEK Bacterial Status
DEN180014 · QFA Assay For Detection Of Proteases In Chronic Wounds · Microbiology
Dec 2019 619d
ID NOW Influenza A & B 2
K190204 · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay · Microbiology
Mar 2019 42d
Alere BinaxNOW Influenza A & B Card 2, Alere Reader
K181853 · PSZ Devices Detecting Influenza A, B, And C Virus Antigens · Microbiology
Aug 2018 28d
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
K173653 · PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · Microbiology
May 2018 155d
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
K173932 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology
Jan 2018 31d
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
K173502 · PSZ Devices Detecting Influenza A, B, And C Virus Antigens · Microbiology
Dec 2017 30d
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
K171792 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology
Sep 2017 105d
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
K162642 · PSZ Devices Detecting Influenza A, B, And C Virus Antigens · Microbiology
Apr 2017 200d
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
K163266 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology
Dec 2016 30d
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
K161375 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology
Aug 2016 92d
BinaxNOW G6PD Test
K161364 · JBF Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening · Hematology
Jun 2016 31d
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
K151464 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology
Jul 2015 57d
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