Data / Medical devices / United States / Abbott Diagnostics Scarborough, Inc.
Abbott Diagnostics Scarborough, Inc.: FDA-registered device maker in Portland, ME, United States, 1 510(k) clearance
Abbott Diagnostics Scarborough, Inc. is registered with the FDA (registration 3029059580) in Portland, ME, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 13, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029059580
- Address
- 65 Gannett Dr, Portland, ME, United States, 04106
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 27, 2014
- Registered through
- 2026
- Brand names listed
- ID NOW Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 13, 2014 | K141520 | ALERE I INFLUENZA A & B | OCC | Substantially Equivalent | Alere Scarborough, Inc D/B/A Binax, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Influenza A And Influenza B Multiplex Nucleic Acid Assay
- All makers of Real Time Nucleic Acid Amplification System
- All makers of Respiratory Virus Panel Nucleic Acid Assay System
Updated June 13, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.