VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.

01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007

Clinical Chemistry and Clinical Toxicology Devices

2

No

The product was shipped nationwide and to Ortho-Clinical/J&J; affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.

VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.