Abbott Diagnostics Scarborough, Inc.
Abbott Diagnostics Scarborough, Inc. holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2026, with 7 FDA device recalls on record.
Top product codes for Abbott Diagnostics Scarborough, Inc.
FDA recalls by Abbott Diagnostics Scarborough, Inc.
- Z-1565-2026 — 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: Not Applicable
- Z-1572-2025 — 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 Acid Assay; Real Time Nucleic Acid Component: No
- Z-1571-2025 — 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 Nucleic Acid Targets Component: No
- Z-1573-2025 — 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
- Z-1574-2025 — 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 Nucleic Acid Targets Component: No
- Z-1575-2025 — 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 Acid Assay; Real Time Nucleic Acid Component: No
- Z-1576-2025 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abbott Diagnostics Scarborough, Inc.
- K262747 — ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
- K250273 — BinaxNOW COVID-19 Ag Card
- K243518 — BinaxNOW COVID-19 Antigen Self Test
- K232775 — ID NOW Influenza A & B 2
- K221925 — ID NOW COVID-19 2.0
- K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
- K191534 — ID NOW Influenza A & B 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.