Medical Device Manufacturer · US , Scarborough , ME

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

6 submissions · 6 cleared · Since 2019

6

Total

6

Cleared

0

Denied

Abbott Diagnostics Scarborough, Inc. has 6 FDA 510(k) cleared medical devices. Based in Scarborough, US.

Latest FDA clearance: Jun 2025. Active since 2019. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Abbott Diagnostics Scarborough, Inc. Filter by specialty or product code using the sidebar.

6 devices

1–6 of 6

BinaxNOW COVID-19 Ag Card

K250273 · QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings · Microbiology

BinaxNOW? COVID-19 Antigen Self Test

K243518 · QYT Over-the-counter Covid-19 Antigen Test · Microbiology

ID NOW Influenza A & B 2

K232775 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology

ID NOW COVID-19 2.0

K221925 · QWR Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings · Microbiology

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

K220801 · OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay · Microbiology

ID NOW Influenza A & B 2

K191534 · OCC Respiratory Virus Panel Nucleic Acid Assay System · Microbiology