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Uma Co., Ltd. D-Dimer Control: 2-19-6 Yokosuka Matsudo, Chiba, Japan

This document provides information about a D-Dimer control kit produced by UMA CO., LTD. in Japan. The kit contains two levels of reconstituted D-Dimer control solutions in 0.5mL vials intended for use as controls with quantitative D-Dimer immunoassays. The controls have a 12-month shelf life when stored between 2-8°C, protected from light. Precautions are outlined for safe handling and disposal of the kit materials due to the human blood origin of the D-Dimer analyte.

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104 views

Uma Co., Ltd. D-Dimer Control: 2-19-6 Yokosuka Matsudo, Chiba, Japan

This document provides information about a D-Dimer control kit produced by UMA CO., LTD. in Japan. The kit contains two levels of reconstituted D-Dimer control solutions in 0.5mL vials intended for use as controls with quantitative D-Dimer immunoassays. The controls have a 12-month shelf life when stored between 2-8°C, protected from light. Precautions are outlined for safe handling and disposal of the kit materials due to the human blood origin of the D-Dimer analyte.

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UMA CO., LTD.

2-19-6 Yokosuka D-Dimer Control


Matsudo, Chiba, Japan

　2 ~ 8 °C Packages
 12 months/block from light 0.5ml x 2 Vial (L, H)
　DO NOT freeze

1. PURPOSE OF USE 5. ASSIGNED VALUE


Control for quantitative determination of Measure D-Dimer Please refer to the package insert for each lot number.
in blood by Immunoassay.
6. STORAGE AND SHELF LIFE
For in Vitro Diagnostics use only.
Storage: Store in cool and dark place (2 ~ 8 C).
2. STRUCTURE AND COMPOSITION OF THE KIT Shelf Life: One Year. Shelf life is printed on the label of kit
Control solution of D-Dimer and stabilizers to maintain D- box.
Dimer for the accurate controls.
7. CONTACT INFORMATION AND MANUFACTURE
Reconstituted Control 0.5 mL × 2 levels set (L, H).
UMA CO., LTD
3. DIRECTION FOR USE 2-19-6 Yokosuka, Matsudo city, Chiba Prefecture, 270-
Preparation method of D-Dimer Control. 0031, Japan
D-Dimer Control is ready for use. Tel: 047-710-4871 Fax: 047-710-4872
Storage
Can be used for one week under storage in refrigerator (2
~ 8 C).
Bring back the refrigerated standard to room temperature
before use.

4. PRECAUTION FOR USE AND HANDLING


- This product is made of human blood as a base. Take
same precautions against infection as patient samples
such as to wear gloves.
Do not pipette by mouth.
- If this product is spilled from the container, disinfect with
80% of alcohol spray and wipe it out wearing gloves for
protection of infection.
- All samples and controls, as well as their containers
must be treated according to the handling manual for
discarding infectious waste materials or treat them
according to the following methods.
 Sterilize with an autoclave, subjecting to high pressure
saturated steam at 121 C for 20 minutes, however do not
process wastes containing sodium hypochlorite with an
autoclave.
 Immerse at least one hour in sodium hypochlorite
solution (active chloride concentration of over 1000 ppm).
- Absolutely do not freeze this product.

1/1 Revision 12/2016

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