Company · US
Abbott Diagnostics Scarborough, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (1 in 12 months)
7recalls (1 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 5 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 4 |
| QWR | Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings | 3 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2026 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc. | OCC |
| Jun 13, 2025 | K250273 | BinaxNOW COVID-19 Ag Card Abbott Diagnostics Scarborough, Inc. | QVF |
| Feb 11, 2025 | K243518 | BinaxNOW COVID-19 Antigen Self Test Abbott Diagnostics Scarborough, Inc. | QYT |
| Oct 10, 2023 | K232775 | ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc. | OCC |
| Aug 10, 2023 | K221925 | ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc. | QWR |
| Jun 24, 2022 | K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 Abbott Diagnostics Scarborough, Inc. | OZE |
| Jul 11, 2019 | K191534 | ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc. | OCC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2026 | Abbott Diagnostics Scarborough, Inc. Product Name: ID NOW" Influenza A & B 2
Model/Catalog Number: 427-000
Software Version: Not Applicable
Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique
Component: Open, Classified |
OZE | K171792 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW RSV 24T
Product Name: ID NOW RSV 24T
Model/Catalog Number: 435-000
Software Version: N/A
Product Description: Respiratory virus panel nucleic acid assay system
Component: No Open, Classified |
OCC | K161375 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic A Open, Classified |
OZE | K232775 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle Open, Classified |
QWR | K221925 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW RSV 24T
Product Name: ID NOW RSV 24T
Model/Catalog Number: 435-000
Software Version: N/A
Product Description: Respiratory virus panel nucleic acid assay system
Component: No Open, Classified |
OCC | K161375 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic A Open, Classified |
OZE | K232775 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle Open, Classified |
QWR | K221925 |