Wako Chemicals USA, Inc.

Lot No.: DJ427, Exp 08-31-12

Immunology and Microbiology Devices

2

No

The product had been sold to 2 customers in the US.

Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics || 1600 Bellwood Road Richmond, VA 23237*** || Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.

Lot TQ087, Exp 02/29/08

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide, including USA, Germany and Canada.

NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***