# Abbott Diagnostics Korea Inc.

FEI: 3015883679
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: ABBOTT LABORATORIES (#1415939)

Address: 65, Borahagal-ro, Giheung-gu, Yongin-si Gyeonggi, 17099, KR

Mandatory US Agent: Alere Inc.

## Products

Total registered: 1
Top product codes: QKP
Regulation §: —

Proprietary names: Panbio™ COVID-19 Antigen Self-Test (Abbott Diagnostics Korea Inc.), BinaxNOW COVID-19 Antigen Self-Test (EUA210264), BinaxNOW COVID-19 Ag Card Home Test (EUA203107), BinaxNOW COVID-19 Ag Card (EUA202537), BinaxNOW COVID-19 Reagent Accessory Pack, BinaxNOW COVID-19 Positive Control Swab Kit

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223015883679%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3015883679