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*Revised January 2010

Established January 2004

EXTEL ^®
HM Control for Fecal Occult Blood Measurement

Be sure to read through these instructions before use.

[Lot Number]    :    Lot XXXAAA    [Expire Date]     :　　January、20XX　　 

[Package Contents]

[Application]

This product is used for sample for the quality control of the EXTEL ® HEMO AUTO, a special-purpose reagent for the fully automatic human fecal hemoglobin analyzer, HM-JACK.

[Procedure]

1.  Reagent Preparation

Add exactly 1mL of distilled water to dissolve. After the solution has been stood for 30 to 45 minutes at

room temperature, gently turn upside down to homogenize and start using.

2.     Storage after reconstitution

After dissolving, the solution remains stable for 1 week when stored at 2 - 8°C,or for 30 days when stored below -30°C.

[Warnings and Precautions]

1.   This product contains ingredients of human origin and when tested for HB antigens, HIV and HCV antibodies gives a negative result. It is possible however that other infectious factors may be present. Be sure therefore to take the same precautions as you would do when handling patient samples by wearing gloves or other protection to prevent infection.

2.   This product contains sodium azide as an antiseptic (0.1% or less). On contact with lead, it reacts vehemently with formation of highly explosive metal azides. When you discard the reagent be sure therefore to dilute and wash with plenty of water.

3.   Do not mix controls of different lot numbers for use.

4.   Do not use controls that have exceeded their shelf life or standards that have been dissolved and stood for 1 week or longer even when stored at 2-8°C.

5.   Do not use the containers and accessories of this product for any other purpose.

[Storage and Shelf Life]

1.   Storage: Store in a dark and cool place (at 2-8°C).

2.   The shelf life is displayed on each container label.

[Target Value]

*Value varied by lot.

[Packaging Unit]

For all inquiries please do not hesitate to contact:

Kyowa Medex Co., Ltd.

Scientific & Technical Affairs Department

1-8-10 Harumi, Chuo-ku, Tokyo 104-6004

Toll Free No.: 0120-17-4898