Siemens Healthcare Diagnostics, Inc.

Material Number 10376770, Lot Number 3JD018, Expiration: April 2015

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico.

ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. || System Information: (For Information Only) || The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. || The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.

Software Version 1.0.2; Lot Numbers: CA1275000080008, CA1275000090009, CA1275000060006, CA1275000050005, CA1275000070007, CA1275000130013, CA1275000100010, CA1275000120012, CA1275000170017, CA1275000260026, CA1275000270027, CA1275000280028, CA1275000240024, CA1275000200020, CA1275000220022, CA1275000410041

Clinical Chemistry and Clinical Toxicology Devices

2

No

Distributed in the states of AZ, CA, and WA, and the countries of Germany, Italy, Spain, and UK.

ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. || The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.

Catalog Number: B01-4840-01; Material Number (SMN)10311896, Lot Numbers: 318706, 332463, expiration dates 2015-06-30, 2015-08-31

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US (nationwide) Distribution and to the countries of : Thailand, Pakistan, Vatican, Guadeloupe, Reunion, French Polynesia , Serbia, Martinique, India, China, Singapore, Brazil, South Africa, Mexico, Canada, Israel, Australia, Egypt, Russian Federation, Indonesia, Rep. Korea (S) ,Unit.Arab Emir., Taiwan ,Argentina ,Chile, Malaysia ,Colombia, Peru, Kazakhstan, Paraguay, Vietnam, Algeria, Austria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Turkey.

ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.

Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)

Immunology and Microbiology Devices

2

No

Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.

IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. || For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

All serial numbers

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- US, Australia, Bahrain, Denmark, Egypt, Egypt, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Republic Korea, Singapore, Slovakia, Spain, and the United Kingdom.

ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. || An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.