SYNCHRON

Part number: 465101  Lot Numbers - Date of Mfg - Expiration Date M310237 - 10/29/2003 - 10/31/2004 M401010 - 01/15/2004 - 01/31/2005  M403026 - 03/05/2004 - 03/31/2005 M406041 - 06/10/2004 - 06/30/2005

Clinical Chemistry and Clinical Toxicology Devices

1

No

US and Canada

SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465

Synchron LX 20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit) Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5 Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry Database).

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and Canada

Synchron LX Systems Version 4.5 || Operating Software

Lot Numbers: M705222 and M706238.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and Canada.

SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. || SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.

Synchron Systems Lactate

All Serial Numbers.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- United States, Afghanistan, Algeria, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.

SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. || An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.