FDA Device Establishments · JSON-LD · Markdown

ABBOTT IRELAND

FEI 3008344661 · Repack or Relabel Medical Device · Status: Active

FEI Number3008344661
Owner / OperatorABBOTT LABORATORIES (#1415939)
AddressDIAGNOSTICS DIVISION, FINISKLIN BUSINESS PARK, SLIGO, -, IE
Mandatory US AgentABBOTT LABORATORIES
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)JIS, JHX
Regulation § (21 CFR)862.1150, 862.1215
Proprietary namesAlinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831); ARCHITECT STAT CK-MB Reagent Kit (LN 2K42-25, 2K42-35); ARCHITECt STAT CK-MB Calibrators (LN 2K42-01)

External sources

Source: openFDA. Public-domain (CC0).