Siemens Healthcare Diagnostics, Inc.

Catalog Number KS850 - lots: X05-076-11, X05-081-11, X05-086-11, X05-090-11, X05-091-11, X05-096-11, X05-101-11, X05-108-11, X05-117-11, X05-122-11, X05-125-11, and X05-126-11.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and Puerto Rico., and the countries of Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Spain, Switzerland, Australia, Japan, South Korea, and Canada.

Dimension Vista(R) Cuvettes || The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.

Catalog number: K6451; Mnemonic: TPSA; lot number 11300BB, exp 10/26/2012

Immunology and Microbiology Devices

3

No

USA Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, FL IL, LA, MD, MI, MN, MS, MT, NC, NH, NJ, NV, NY, OH, PA, SD, TN, TX, UT, WI ,WV including Puerto Rico.

Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge || Product Usage: || The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System

Lot numbers 211214002, exp 04/28/2012; 211227002, exp 05/11/2012; 211283002, 07/06/2012; 211297002, 07/20/2012; 211339002, 08/31/2012; 212003002, exp 09/29/2012; and 212023002, exp 10/19/2012.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide distribution: USA including states of: AK, AR, CA, CO, CT, DC, FL, HI, ID, IN, IL, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NH, NM, ND, NY, OH, OK, OR, PA, SD, TX, UT, VT, WA, WV, WI, and WY.

Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) || The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.

Lots 12135AE and 12171BB

Clinical Chemistry and Clinical Toxicology Devices

2

No

USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.

Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) || The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.

Catalog Number: RF421C; Lot Number: FB9037. Expires February 6, 2009.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia.

Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). || The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.