ADVIA

All serial numbers of ADVIA 560 Hematology Systems.

Hematology and Pathology Devices

2

No

Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of : Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.

ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD || The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories

Kit lots 348297 & 359932.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.

ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. || For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.

Device Listing: Enzymatic Creatinine_2 D033075; Catalog # 74330

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

ADVIA CHEMISTRY ENZYMATIC CREATININE_2

Device Listing: Glucose Oxidase (GLUO) D11793, Catalog # 74020 & Concentrated Glucose Oxidase (GLUO_c) D117943, Catalog # 74721

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

Device Listing: D126071, Triglyceride_2, Catalog # 74082 Device Listing: D211156, Triglyceride Concentrated, Catalog # 74084

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT