Safety Data Sheet

Data of issue: 2017-09-10

1. Identification of the substance / mixture and of the company/undertaking
Information of the product
Product code 0031-30-60615（3ml/High）0031-30-60615（3ml/Normal） 0031-30-60615（3ml/Low）
Product name B30 CONTROL
Use of the substance Controls for Hematology.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.，LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R. China, 508057
Tel:+86 755 26582888 / Fax:+86 755 26582680
Enquiry point Research & Development of Reagent Department
Tel:+86 755 26582888 Fax:+86 755 26582680(Mon-Fri; 08:30-18:00 Beijng Time)
Reagent Production Department
Tel: +86 75586159564 / Fax:+86 755 86159563(Mon-Fri; 08:30-18:00 Beijng Time)
2. Hazards identification
Classification for supply This preparation is not dangerous under 1999/45/EC regulations and subsequent amendments.
Health hazards See Section 11 for more information
Environmental hazard See Section 12 for more information
Physico-chemical hazard No information available
Other hazards Each human whole blood donor unit used to manufacture this product was tested by reagents box using ELISA
methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and
antibody to HIV-1/HIV-2. However, as no testing method can rule out the risk of potential infection with absolute
certainty, this product should be handled as a potentially infectious material. In the event of exposure follow the
directives of the responsible health authorities.
3. Composition / information on ingredients
Composition This product is a suspension of simulated white cells (fixed animal red cells), stabilized human erythrocytes and
simulated platelets (fixed animal red cells or platelets) in a medium containing stabilizers and preservatives.
4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.
Inhalation Not applicable.
Ingestion Drink lots of water. Seek medical advice immediately.

Fire and explosive properties
Extinguishing media
Special exposure hazard
Protective equipment for fire-fighter
5. Fire-fighting measures
The product is water based, and not flammable or explosive.
CO2, extinguishing powder or water spray.
None
Fire fighters should wear an approved self-contained breathing apparatus and full protective clothing.

6 Accidental release measures

Personal precautions
Environmental precautions
Methods for cleaning up
Wear gloves and laboratory coat. Prevent skin and eye contacting.
keeping away from drains, surface- and ground-water and soil.
As a precautionary measure, treat spilled material with a 1:10 bleach/water solution. Absorb liquid and
place in containers suitable for disposal. Avoid generation of aerosols during clean up. Comply with
applicable waste disposal regulations.

7 Handling and storage

Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling
Handling
this product.
Storage Store at 2-8℃, Keep container closed.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Not necessary.
Personal exposure equipment Standard laboratory latex or rubber gloves recommended.
Environmental exposure controls Not necessary.
 9 Physico-chemical properties
Appearance Red or dark-red liquid. Relative density Not determined
Odour Odourless Specific gravity Not determined
pH-value ( 25 °C ) 6.5-7.5 Solubility in water Fully miscible
Melting point 0 °C Solubility in solvents No information available.
Boiling point 100 °C Partition coefficient Not applicable.
Flash point Not applicable. Viscosity No information available.
Explosive properties Not explosive. Vapour density Not applicable.
Oxidizing properties Not applicable. Evaporation rate Not applicable.
Autoignition temperature Not applicable. Corrosivity to metal Not corrosive.
Vapour pressure No information available
10 Stability and reactivity
Stability This product is stable for 3 months.
Conditions to avoid Frozen, high temperature
Materials to avoid and
hazardous decomposition No information available.
product

11 Toxicological information
Toxicokinetics, metabolism and distribution No experimental data for this preparation available.
Acute toxicity No experimental data for this preparation available.
Corrosivity/irritation No corrosive/irritant effect.
Sensitisation No experimental data for this preparation available.
Repeated-dose toxicity No experimental data for this preparation available.
Carcinogenicity/Mutagenicity/Reproduci tive
toxicity No experimental data for this preparation available.

12 Ecological information
Ecotoxicity No information available. Bioaccumulation potential No information available.
Mobility No information available. Resultsof PBT assessment No information available.

Persistence/degradability No information available. Other adverse effects No information available.

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental requirements.
Packing Dispose of contaminated packaging in accordance with governmental requirements.

14 Transport information
Transport / further This substance is not dangerous under current provisions of the Code of International Carriage of
information Dangerous Goods by Road (ADR) and by Rail (RID), of the International Maritime Dangerous Goods Code
(IMDG), and of the International Air Transport Association (IATA) regulations.

15 Regulations
Classification Preparation not classified.
and labelling
according DIRECTIVE 1999/45/EC
to ED Directives REGULATION (EC) No 1907/2006 REACH
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC

16 Other information
Revisions:A
Information of this Safety Data Sheet represents the today’s state of our knowledge. The purpose is to characterise the product regarding
safety precautions having to be kept. This document will not be a certification of features and will not be the basis of a legal contract.