Product numbers: 06F16-02, 210000, 210001, 210002, 210003; all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Kong, India, Ireland, Israel, Japan, Kingdom of Saudi Arabia, Korea, Kuwait, Mauritius, Mexico, Nigeria, Norway, Panama, Paraguay, Peoples Republic of China, Peru, Poland, Portugal, Qatar, Russia, Singapore, South Africa, Spain, Sweden, UK, Sultanate of Oman, Switzerland, Taiwan, R.O.C., Thailand, Turkey, UAE, Uruguay, and Yemen.

i-STAT Portable Clinical Analyzer; || Abbott Point of Care, Princeton, NJ 08540 || Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

Product numbers: 04J48-01, 215000; all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Kong, India, Ireland, Israel, Japan, Kingdom of Saudi Arabia, Korea, Kuwait, Mauritius, Mexico, Nigeria, Norway, Panama, Paraguay, Peoples Republic of China, Peru, Poland, Portugal, Qatar, Russia, Singapore, South Africa, Spain, Sweden, UK, Sultanate of Oman, Switzerland, Taiwan, R.O.C., Thailand, Turkey, UAE, Uruguay, and Yemen.

Military Kit Portable Clinical Analyzer; || Abbott Point of Care, Princeton, NJ 08540 || Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.

Lot # MV0146

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.

Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712. || Assayed quality control material for use with the Cholestech LDX System.

Lot # MC0146

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.

Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713. || Assayed quality control material for use with the Cholestech LDX System.

Lot # SV0146

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.

Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982. || Assayed quality control material for use with the Cholestech LDX System.

Lot # SC0146

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.

Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. || Assayed quality control material for use with the Cholestech LDX System.

Lot # 0146

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.

Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. || To be used for verifying the reportable range of tests on the Cholestech LDX System.

List numbers: 07G01-01, 07G01-02,. 600-9006-25; Lot numbers: S10127B, S10136A, S10150A, S10151, S10155.

Hematology and Pathology Devices

2

No

Worldwide Distribution

i-STAT ACT Celite Cartridges || in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.

List numbers: 07G81-01, 07G81-02; Lot numbers: S10129, S10129A, S10130, S10130B, S10147A, S10147B, S10147C, S10147D, S10147E, S10148A, S10148B, S10148C, S10148D, S10148G, S10149, S10149B, S10149C, S10151A, S10151B, S10152, S10152A, S10152B, S10152C, S10152D, S10152E, S10152F, S10154A, S10154B, S10154D, S10160B, S10162.

Hematology and Pathology Devices

2

No

Worldwide Distribution

i-STAT ACT Kaolin Cartridges || in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.