# ABBOTT IRELAND

FEI: 3008344661
Status: Active
Establishment types: Repack or Relabel Medical Device
Owner/operator: ABBOTT LABORATORIES (#1415939)

Address: DIAGNOSTICS DIVISION, FINISKLIN BUSINESS PARK, SLIGO, -, IE

Mandatory US Agent: ABBOTT LABORATORIES

## Products

Total registered: 2
Top product codes: JIS, JHX
Regulation §: 862.1150, 862.1215

Proprietary names: Alinity 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)

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223008344661%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3008344661