Security Classification: Secret Z-003J-009-SJ-3.

Safety Data Sheet

SECTION 1: Identification of the substance/mixture and of the company/
undertaking
1.1. Product identifier
Product name: Hematology Control.
Model: BC-5D.
Product code: 105-003229-00(High, 3mL×6); 105-003230-00(Normal, 3mL×6);
105-003231-00(Low, 3mL×6); 040-000021-00(Low, 3mL×6);
040-000019-00(Normal, 3mL×6); 040-000020-00(High, 3mL×6);

040-000025-00(Low, 3mL×12); 040-000023-00(Normal, 3mL×12)

040-000024-00(High, 3mL×12);
105-003232-00(High, 3mL×1; Normal, 3mL×1; Low, 3mL×1);
105-003233-00(High, 3mL×2; Normal, 3mL×2; Low, 3mL×2);
040-000018-00(High, 3mL×2; Normal, 3mL×2; Low, 3mL×2);
040-000022-00(High, 3mL×4; Normal, 3mL×4; Low, 3mL×4).
1.2. Relevant identified uses of the substance or mixture and uses advised against
Intended use: Controls for Hematology. For more information, see instruction for use
and labels.
1.3. Details of the supplier of the safety data sheet
Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Adress：Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan,
Shenzhen, 518057, P. R. China.
Tel: +86 755 81888998 / Fax: +86 755 26582680
E-mail Address: [email protected]
1.4. EC-Representative

EC-Representative：Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestraβe 80, 20537 Hamburg, Germany

Tel: 0049-40-2513175 Fax: 0049-40-255726
1.5. Emergency telephone number
Emergency telephone No: +86 755 81888998 (Mon-Fri; 08:30-18:00 Beijing Time)
SECTION 2: Hazards identification

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2.1. Classification of the substance or mixture

This product is belong to mixture.

This product does not meet the criteria for classification in any hazard class
according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of
substances and mixtures.
2.2. Label elements
Hazard pictograms: Not Applicable.
Signal word: Not Applicable.
Hazard statements: Not Applicable.
Precautionary statements: P501: Dispose of waste product, unused product,
contaminated packaging in accordance with governmental requirements.
2.3. Other hazards

PBT, vPvB, carcinogens, mutagens, reproductive toxicants: This product does not
contain any known PBT, vPvB, carcinogens, mutagens, reproductive toxicants as listed
by SVHC candidate list.
This product was tested by reagents kit using ELISA methods and found
non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV),
antibody to HIV-1/HIV-2 and antibody to Treponema Pallidum (TP). 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.
SECTION 3: Composition/information on ingredients
3.1. Substances

Not Applicable.
3.2. Mixtures
Name CAS NO. Concentration

Human or Animal Sourced Material Not Applicable 5 – 50

Preservatives and Other Non-Hazardous Not Applicable 50 –95
Ingredients
Sodium Azide 26628-22-8 <0.1%
SECTION 4: First aid measures

4.1. Description of first aid measures

Skin contact If this chemical contacts the skin, flush the area of skin with

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plenty water. If clothing becomes wet or significantly

contaminated, remove and replace clothing. Where there is
evidence of skin irritation, get medical attention.
Immediately flush eye(s) with large volumes of water for at
Eye contact least 15 minutes, occasionally lifting the lower and upper lids.
Get medical attention immediately.
Get medical attention if there has been ingestion of this
product. Do not give anything by mouth to an unconscious
Ingestion
person. Do not induce vomiting unless directed by medical
personnel.
The product is water based with slight volatilization, so there
is a very small chance of inhalation. If the product is inhaled,
Inhalation
move exposed individual to fresh air, and seek medical
assistance immediately.
Medical Show this safety data sheet to medical personnel. Give
treatment symptomatic treatment and supportive therapy.

4.2. Most important symptoms and effects, both acute and delayed

Acute symptoms Not Applicable

Delayed symptoms Not Applicable
4.3. Indication of any immediate medical attention and special treatment needed

Not Applicable
SECTION 5: Firefighting measures
5.1. Extinguishing media

Use fire extinguishing media appropriate for site conditions, such as CO2,
extinguishing powder or water spray.
5.2. Special hazards arising from the substance or mixture

Not applicable
5.3. Advice for firefighters
Fire fighters should wear an approved self-contained breathing apparatus and full
protective clothing.
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures

Wear gloves and laboratory coat. Prevent skin and eye contacting.

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6.2. Environmental precautions
Keeping away from drains, surface and ground water and soil.
6.3. Methods and material for containment and cleaning up
As a precautionary measure, treat spilled material with a 1:10 bleach/water solution.
Absorb spill with inert material (e.g. vermiculite, sand or earth) and place in containers
suitable for disposal. Avoid generation of aerosols during clean up. Dispose it in
accordance with governmental requirements.
6.4. Reference to other sections

See Sections 8 and 13 for more information.

SECTION 7: Handling and storage
7.1. Precautions for safe handling

Avoid getting this product ON YOU or IN YOU.

Wash hands thoroughly after handling this product. Do not eat, drink, smoke, or apply
cosmetics while handling this product. Use in a well-ventilated ___location. Remove
contaminated clothing immediately.
7.2. Conditions for safe storage, including any incompatibilities
All employees who handle this material should be trained to handle it safely.
Avoid contact with eyes, skin, and clothing. Empty containers should be completely
drained and disposed of properly. Containers of this product must be properly labeled.
Storage areas of this product should be clearly identified, well illuminated, clear of
obstruction and accessible only to trained and authorized personnel. Store containers in
a cool, dry ___location away from direct sunlight at temperatures between 2-8℃. Keep
product away from freezing. Keep container tightly closed when not in use. Observe all
warnings and precautions listed for this product.
7.3. Specific end use(s)
Not Applicable.
SECTION 8: Exposure controls/personal protection
8.1. Control parameters

Impervious gloves, such as Nitrile or equivalent, should

Skin protection
be worn to prevent skin contact.
Safety glasses or chemical goggles should be worn to
Eye protection
prevent eye contact.

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Under normal conditions, the use of this product should

not require respiratory protection. If overexposure
Respiratory should occur and ventilation is not adequate to
protection maintain airborne concentrations at acceptable levels,
the use of respiratory protection should be evaluated by
a qualified professional.
Enviromental Prevent the product from entering drains and
exposure controls watercourses.

8.2. Exposure controls

Follow the usual biosafety practices for handling potentially infectious materials. Use
in well ventilated area. Keep away from foodstuffs, beverages and feed. Remove all
soiled and contaminated clothing immediately. Wash hands before breaks and at the end
of work.
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties

Appearance Red Liquid.

Odour Little to none.
Odour threshold Not applicable.
pH Neutra.
Melting No information available.
point/freezing point
Initial boiling point No information available.
and boiling range
Flash point (typical) Not applicable.
Evaporation rate Not applicable.
Flammability (solid, Not applicable. The product is water based, and not
gas) flammable or explosive.
Upper/lower Not applicable. The product is water based, and not
flammability or flammable or explosive.
explosive limits
Vapour pressure Not applicable.
Vapour density Not applicable.
Relative density No information available.
Solubility(ies) Fully miscible in water.

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Partition Not applicable.

coefficient:
n-octanol/water
Auto-ignition Not applicable. The product is water based, and not
temperature flammable or explosive.
Decomposition Not applicable.
temperature
Viscosity No information available.
Explosive Not applicable. The product is water based, and not
properties flammable or explosive.
Oxidizing Not applicable.
properties

9.2. Other information

No information available.
SECTION 10: Stability and reactivity
10.1. Reactivity

This product contains low concentrations of Sodium Azide <0.1% (w/w). Sodium
Azide can form explosive compounds with heavy metals which, with repeated contact
with lead and copper commonly found in plumbing drains may result in the build up of
shock sensitive compounds.
10.2. Chemical stability
This product is stable under conditions specified by instruction for use and labels.
10.3. Possibility of hazardous reactions

Not applicable.
10.4. Conditions to avoid

Avoid Frozen and high temperature(above 8℃). Keep away from sunlight.

10.5. Incompatible materials

Metals and metallic compounds.
10.6. Hazardous decomposition products
When stored as labeled, no known hazardous decomposition products are formed
during the shelf-life of this product.
SECTION 11: Toxicological information

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11.1. Information on toxicological effects

Toxicokinetics,
metabolism and No experimental data for this preparation available.
distribution
Acute toxicity No experimental data for this preparation available.
Skin No experimental data for this preparation available.
corrosion/irritation
Serious eye No experimental data for this preparation available.
Damage/irritation
Respiratory or skin No experimental data for this preparation available.
Sensitisation
Germ cell No experimental data for this preparation available.
mutagenicity
Carcinogenicity No experimental data for this preparation available.
Reproductive toxicity No experimental data for this preparation available.
STOT-single No experimental data for this preparation available.
exposure
STOT-repeated No experimental data for this preparation available.
exposure
Aspiration hazard No experimental data for this preparation available.

SECTION 12: Ecological information

12.1. Toxicity

Not applicable.
12.2. Persistence and degradability
Not applicable.
12.3. Bioaccumulative potential

Not applicable.
12.4. Mobility in soil
Not applicable.
12.5. Results of PBT and vPvB assessment

Not applicable.
12.6. Other adverse effects
Not applicable.
SECTION 13: Disposal considerations
13.1. Waste treatment methods
Dispose of waste product, unused product and contaminated packaging in

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accordance with local requirements. To ensure compliance we recommend that you
contact the relevant(local) authorities and/or an approved waste-disposal company for
information.
SECTION 14: Transport information
14.1. UN number
Not applicable.
14.2. UN proper shipping name
Not applicable.
14.3. Transport hazard class(es)
Not applicable.
14.4. Packing group
Not applicable.
14.5. Environmental hazards

This product is not designated as a marine pollutant by the Department of

Transportation.
14.6. Special precautions for user

See chapter 7 and chapter 8 for information.

14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code
Not applicable.
SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance
or mixture
EU regulations: This SDS complies with EC Regulations 1907/2006 (REACH) and
amendments.
US Federal and State Regulations:
CERCLA/SARA 302: Sodium Azide is listed.
CERCLA/SARA 304: Sodium Azide is listed.
SARA 313: Sodium Azide is listed.
TSCA (Toxic Substances Control Act): Sodium Azide is listed.
Canada: This product is exempt from WHMIS requirements.
15.2. Chemical safety assessment

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No Chemical Safety Assessment has been carried out for this substance/mixture by
the supplier.
SECTION 16: Other information

Date of last revision(year/month/day): 2015/12/08 Replaces edition of 2.0

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.
The primary changes in 3.0 as follows:
1. Add the product code of transit trade product.

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