Abbott Diagnostics Scarborough, Inc.
Medical device manufacturer in Scarborough, ME.
7510(k) clearances
1PMA approvals
7recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0OCC · Special | 08/31/2026SE |
| K250273 | BinaxNOW COVID-19 Ag CardQVF · Dual Track | 06/13/2025SE |
| K243518 | BinaxNOW COVID-19 Antigen Self TestQYT · Traditional | 02/11/2025SE |
| K232775 | ID NOW Influenza A & B 2OCC · Special | 10/10/2023SE |
| K221925 | Id Now COVID-19 2.0QWR · Dual Track | 08/10/2023SE |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2OZE · Special | 06/24/2022SE |
| K191534 | ID NOW Influenza A & B 2OCC · Special | 07/11/2019SE |
PMA approvals
- P940035 NMP22 BladderChek Test · 07/02/1996 · 17 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1565-2026 Class II | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version:…It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product… | 02/09/2026Open, Classified |
| Z-1576-2025 Class II | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000…the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 03/04/2025Open, Classified |
| Z-1575-2025 Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T…the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 03/04/2025Open, Classified |
| Z-1574-2025 Class II | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog…the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 03/04/2025Open, Classified |
| Z-1573-2025 Class II | Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000…The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 03/04/2025Open, Classified |
| Z-1572-2025 Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T…The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 03/04/2025Open, Classified |
| Z-1571-2025 Class II | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog…The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 03/04/2025Open, Classified |