VITROS Chemistry Products PHYT Slides

ivd

Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - US Distribution including Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.

VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. || For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Unique Identifier No.: 10758750004690 Product Code: 8298671 Affected Generation: GEN 16 Coating ID: Coating 0165 Expiry Dates: 15 March 2018 Through 15 June 2018

Chemistry analyzers, Laboratory

In-vitro diagnostics

VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics Inc