Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''

Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.

Hematology and Pathology Devices

2

No

Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.

Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''