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1302172

Collaborative Care Diagnostics, LLC. — FEI 3002619777

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 9, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Eagan, MN (United States)

Facility

Other inspections at this facility

  • 1155197 (VAI Mon Oct 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966212 (NAI Wed Feb 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754147 (NAI Fri Oct 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 579761 (NAI Tue May 05 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
2279621 CFR 801.40(a)Form of a unique device identifier
2280021 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23134ISO 13485:2016 Clause 7.3.9Review of design and development do not include evaluation of change effects