FDA Device Establishments · JSON-LD · Markdown

Abbott Diagnostics Korea Inc.

FEI 3015883679 · Manufacture Medical Device · Status: Active

FEI Number3015883679
Owner / OperatorABBOTT LABORATORIES (#1415939)
Address65, Borahagal-ro, Giheung-gu, Yongin-si Gyeonggi, 17099, KR
Mandatory US AgentAlere Inc.
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)QKP
Proprietary namesPanbio™ 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

External sources

Source: openFDA. Public-domain (CC0).