i-STAT

i-STAT Catalog Number -- 420300; Abbott Catalog Number -- 07G01-01 (USA and Canada); Abbott Catalog Number -- 07G10-02 (Rest of world).  Lot Numbers: R04174B; R04175; R04175A; R04183; R04183A; R04183B; R04183C; R04190A; R04190B; R04205; R04205A; R04212A; R04212B; R04233; R04239; R04245; R04245A; R04245B; R04253; R04261; R04261A; R04262; R04274; R04274A; R04275; R04293; R04293A; R04294; R04294A; R04305; R04305A; R04305B; R04306; R04309; R04309A; R04315; R04315A; R04315B; R04322; R04323; R04323A; R04329; R04337; R04337A; R04342; R04343; R04350; R04350A; R04350B; R05006; R05014; R05014A; R05032B; R05032C; R05043; R05043A; R05044; R05048B; R05048C.

Hematology and Pathology Devices

2

No

The cartridges have been distributed to hospitals and clinics nationwide. The cartridges have been distributed to Austria, Australia, Canada, Switzerland, China, Colombia, Germany, France, Greece, Hong Kong, India, New Zealand, and Singapore. There are 15 VA hospitals identified. There are 3 government and military accounts.

i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.

Product: Blood Analyzers Abbott Point of Care Model : i-STAT Wireless (300W) List Number: 03P75-XX Abbott Point of Care Model : i-STAT Alinity Insturments List Number: Not Listed.

Analyzers, Laboratory, Clinical Chemistry

List number(s): JAMS142E, 03P86-25, 03P87-25 Lot/Serial Number(s): All (for cartridges) Unique Device Identifier(s) (UDI): Primary GTIN 10054749000149 Primary GTIN 10054749000156

IVD Test Reagent/Kits, Hematology