SAFETY DATA SHEET
5035C
Siemens Medical Solutions Diagnostics Emergency Telephone
511 Benedict Avenue 1-800-424-9300 (Chemtrec)
Tarrytown, NY 10591; USA Technical Information
1-877-229-3711
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND
THE COMPANY/UNDERTAKING
Product Name: DCA System Hemoglobin A1c Reagents Test Kit
Product Number: 5035C
Date Prepared: 4/1/2007
Revision Number: 4
Recommended Use: In vitro diagnostic reagent
2. COMPOSITION/INFORMATION ON INGREDIENTS
CAS-No./EINECS- Chemical Name Amount EU Classification
No. (67/548/EEC):
556-65-0 / 209-135- Lithium 5.7% Xn, R22, R32
1 Thiocyanate (Buffer
only)
See Section 16 for further information on EU Classification.
3. HAZARDS IDENTIFICATION
This product is not considered to be a critical hazard to man or the environment.
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
4. FIRST AID MEASURES
Inhalation, Skin Contact and Eye Contact: If contact with contents occurs, wash
area with water. Get medical attention if irritation persists.
Ingestion: Have patient drink 2-8 oz. glasses of water or milk to dilute. Get immediate
medical attention.
5. FIRE-FIGHTING MEASURES
Extinguishing Media: Use whatever is required for the surrounding area.
Special Fire Fighting Procedures: It is always best to wear a self-contained
breathing apparatus.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 1
SAFETY DATA SHEET
5035C
Unusual Fire and Explosion Hazards: Thermal decomposition may yield small
amounts of hydrogen cyanide.
6. ACCIDENTAL RELEASE MEASURES
Steps to be taken in case material is released or spilled: Pick up and place in a
disposal container. Collect spilled liquid with absorbent material and place in container for
disposal.
7. HANDLING AND STORAGE
Store at temperatures and conditions as indicated on the product label.
Avoid contact with the reagents in the cartridge. Wash thoroughly after handling.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Chemical Name Exposure Limit(s)
Lithium Thiocyanate (Buffer only) None Established
Ventilation: Use general room ventilation, there is no special respiratory protection
required.
Protective Gloves and Other Protective Equipment: Standard laboratory latex
or plastic gloves.
Eye Protection: Standard laboratory safety glasses recommended.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance and odor: Plastic test cartridge with trace amounts of reagents and 600
uL of clear liquid buffer solution.
pH: buffer solution 9.0
Solubility in Water: Chemical contents are soluble.
Physical Characteristics: not significant
Flash Point (Method Used): None
Flammable Limits: LEL: Not Applicable UEL: Not Applicable
10. STABILITY AND REACTIVITY
Stability: This product is stable as sold if used as directed. There are no specific
conditions to avoid.
Reacts with acids to liberate highly toxic cyanide compounds including hydrogen cyanide.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 2
SAFETY DATA SHEET
5035C
11. TOXICOLOGICAL INFORMATION
Chronic Effects of Overexposure: None currently known. None of the components
are listed as a carcinogen or suspected carcinogen.
Acute Toxicity:
Inhalation, Skin Contact and Eye Contact: Inhalation of mists may cause
respiratory irritation and possible systemic effects similar to ingestion. Contact may cause
irritation.
Ingestion: Swallowing may cause gastrointestinal irritation and toxic effects including
weakness, nausea, confusion, headache, slow gasping respiration, and cyanosis. This
product contains microgram quantities of some hazardous components. These are contained
within the test cartridge, so exposure is unlikely and the total amounts are insufficient to
cause health effects.
Acute Toxicity Values: Lithium Thiocyanate: LD50 oral mouse: 210 mg/kg
12. ECOLOGICAL INFORMATION
Ecological effects of this mixture have not been determined.
13. DISPOSAL CONSIDERATIONS
Primary Container Type: The product container is HD polyethylene.
Waste Disposal Method: Each disposal facility must determine proper disposal
methods to comply with Local, State and Federal Environmental Regulations. Incineration
of the product could produce trace amounts of toxic gasses. Check your local regulations
before incineration
14. TRANSPORT INFORMATION
Proper Shipping Name: Not regulated
Technical Name:
UN Number: N/A
Hazard Class and Packaging Group: Not regulated
Label(s): N/A
Packing Instruction (Passenger Aircraft): N/A
Packing Instruction (Cargo Aircraft): N/A
Unit Volume: 600 uL buffer/cartridge
Primary Container Type: Plastic, HD polyethylene
Sales Unit: 10 cartridges
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 3
SAFETY DATA SHEET
5035C
15. REGULATORY INFORMATION
SARA 311/312: Hazard categories for SARA Section 311/312 Reporting:
Acute Health
Canadian WHMIS Classification: Medical Devices are Exempt from WHMIS
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
16. OTHER INFORMATION
HMIS Hazard Rating 4 Severe Hazard
3 Serious Hazard
HEALTH 1 2 Moderate Hazard
FLAMMABILITY 0 1 Slight Hazard
REACTIVITY 0 0 Minimal Hazard
PERSONAL_PROTECTION A * An asterisk indicates significant chronic health effects
EU Classes and Risk Phrases for Reference (See Sections 2 and 3):
Xn - Harmful
R22 - Harmful if swallowed.
R32 - Contact with acids liberates very toxic gas.
Reason for Revision: Revisions to section(s) 1
Prepared by: Regulatory Affairs Department
The opinions expressed herein are those of qualified experts within Siemens Medical
Solutions Diagnostics. We believe that the information contained herein is current as of the
date of this Material Safety Data Sheet. Since the use of this information and these
opinions and the conditions of use of the product are not within the control of Siemens
Medical Solutions Diagnostics, it is the users' obligation to assure safe use of the product.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 4
SAFETY DATA SHEET
5068A
Siemens Medical Solutions Diagnostics Emergency Telephone
511 Benedict Avenue 1-800-424-9300 (Chemtrec)
Tarrytown, NY 10591; USA Technical Information
1-877-229-3711
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND
THE COMPANY/UNDERTAKING
Product Name: DCA Systems Hemoglobin A1c Normal & Abnormal Control
Product Number: 5068A
Date Prepared: 4/1/2007
Revision Number: 3
2. COMPOSITION/INFORMATION ON INGREDIENTS
This product contains several components. Please refer to the individual Safety Data Sheets
for the components listed below.
Component Name Product Number
Reconstitution Fluid 5068-RF
Hemoglobin A1c Normal Control 8377GR
Hemoglobin A1c Abnormal Control 8378GR
Products may contain components which require reporting under SARA Title III Section
313 (40 CFR 372). See applicable component MSDS.
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
14. TRANSPORT INFORMATION
Proper Shipping Name: Not regulated
Technical Name:
UN Number: N/A
Hazard Class and Packaging Group: N/A
Label(s): N/A
Packing Instruction (Passenger Aircraft): N/A
Packing Instruction (Cargo Aircraft): N/A
Shipping Container Type: N/A
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 1
SAFETY DATA SHEET
5068A
Sales Unit: 1 plastic bottles with non-hazardous liquid 4 glass bottles with non-
hazardous powder in a fiberboard carton as a kit.Prepared by: Regulatory Affairs
Department
HMIS Hazard Rating 4 Severe Hazard
3 Serious Hazard
HEALTH 1 2 Moderate Hazard
FLAMMABILITY 0 1 Slight Hazard
REACTIVITY 0 0 Minimal Hazard
PERSONAL_PROTECTION C * An asterisk indicates significant chronic health effects
The opinions expressed herein are those of qualified experts within Siemens Medical
Solutions Diagnostics. We believe that the information contained herein is current as of the
date of this Material Safety Data Sheet. Since the use of this information and these
opinions and the conditions of use of the product are not within the control of Siemens
Medical Solutions Diagnostics, it is the users' obligation to assure safe use of the product.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 2
SAFETY DATA SHEET
5068-RF
Siemens Medical Solutions Diagnostics Emergency Telephone
511 Benedict Avenue 1-800-424-9300 (Chemtrec)
Tarrytown, NY 10591; USA Technical Information
1-877-229-3711
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND
THE COMPANY/UNDERTAKING
Product Name: Reconstitution Fluid
Product Number: 5068-RF
Date Prepared: 4/1/2007
Revision Number: 5
Recommended Use: In vitro diagnostic reagent
2. COMPOSITION/INFORMATION ON INGREDIENTS
CAS-No./EINECS- Chemical Name Amount EU Classification
No. (67/548/EEC):
26628-22-8 / 247- Sodium Azide 0.09% N, T+, R28, R32,
852-1 R50/53
See Section 16 for further information on EU Classification.
3. HAZARDS IDENTIFICATION
Man: May be harmful by ingestion. May cause irritation.
Environment: This product contains 0.09% sodium azide which is toxic to fish.
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
4. FIRST AID MEASURES
Emergency First Aid Procedures: Call a physician immediately. Arrange for
transport to the nearest ER (emergency room).
While awaiting the physician or transport to the ER:
Inhalation: If it occurs move patient to fresh air. If not breathing, give artificial
respiration. If breathing is difficult, give oxygen.
Ingestion: If the patient is conscious, wash out mouth with water, give one or two glasses
of water or milk to dilute immediately. Get immediate medical attention.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 1
SAFETY DATA SHEET
5068-RF
Skin Contact: Take off all contaminated clothing immediately. Wash off with soap and
plenty of water. Wash contaminated clothing before re-use.
Eye Contact: Rinse immediately with plenty of water, also under the eyelids, for at least
15 minutes. Transport to hospital for further medical attention.
5. FIRE-FIGHTING MEASURES
Extinguishing Media: Use whatever is required for the surrounding area.
Special Fire Fighting Procedures: It is always best to wear a self-contained
breathing apparatus.
Unusual Fire and Explosion Hazards: None determined.
6. ACCIDENTAL RELEASE MEASURES
Steps to be taken in case material is released or spilled: Take up with
absorbent material and place in a suitable container. Wipe up area with a damp paper
towel and discard.
7. HANDLING AND STORAGE
Store at temperatures and conditions as indicated on the product label. Avoid contact with
the eyes, skin and clothing.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Chemical Name Exposure Limit(s)
Sodium Azide 0.29 mg/m3 TLV-Ceiling
Ventilation: Use general room ventilation.
Respiratory Equipment: None required.
Protective Gloves: Standard laboratory chemical rubber or latex gloves.
Eye Protection: Standard laboratory safety glasses recommended. Contact lenses
should not be worn in the laboratory.
Other Protective Equipment/Clothing: A laboratory coat or apron is suggested.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance and odor: Clear, colorless, aqueous solution.
pH: N/D
Specific Gravity (H2O=1): N/D
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 2
SAFETY DATA SHEET
5068-RF
Boiling Point (F): N/D
Melting Point (F): N/A
Vapor Pressure: N/D
Evaporation Rate: N/D
Solubility in Water: Soluble
Flash Point (Method Used): None
Flammable Limits: LEL: Not Applicable UEL: Not Applicable
N/A = Not Applicable N/D = Not Determined
10. STABILITY AND REACTIVITY
Stability: Stable
Conditions to Avoid: None determined.
Substances to Avoid: Avoid contact with metals (aluminum, mercury, copper, lead,
zinc) and acids.
Hazardous Decomposition Products: Sodium azide can react with heavy metals to
form explosive azides.
Hazardous Polymerization: Will Not Occur
11. TOXICOLOGICAL INFORMATION
Chronic Effects of Overexposure: None currently known.
Carcinogen or Suspected Carcinogen: None of the components are listed as a
carcinogen or suspected carcinogen.
Medical Conditions Aggravated by Exposure: None currently known.
Acute Toxicity:
Inhalation: Inhalation of mists may cause respiratory irritation and possible systemic
effects similar to ingestion.
Ingestion: Ingestion of sodium azide has been reported to cause shortness of breath,
nausea, vomiting, restlessness, diarrhea, lowering of blood pressure (hypotension), and
collapse. Rated highly toxic in animals.
Skin Contact: May cause mild irritation. Prolonged and extensive skin contact may
result in absorption with systemic symptoms similar to ingestion.
Eye Contact: May cause irritation.
Acute Toxicity Values: Sodium Azide: LD50 oral rat: 27 mg/kg; LD50 dermal rabbit:
20 mg/kg
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 3
SAFETY DATA SHEET
5068-RF
12. ECOLOGICAL INFORMATION
Ecological effects of this mixture have not been determined. The LC50 for sodium azide in
Daphnia Pulex is reported to be 4.2 mg/L/96 hr @ 15篊 and in Rainbow Trout is reported to
be 0.8-1.6 mg/L/96 hr @ 13篊, Wt 1.4 G.
13. DISPOSAL CONSIDERATIONS
Primary Container Type: The product container is LD Polyethylene.
Waste Disposal Method: Each disposal facility must determine proper disposal
methods to comply with Local, State and Federal Environmental Regulations.
14. TRANSPORT INFORMATION
Proper Shipping Name: Not regulated
Technical Name:
UN Number: N/A
Hazard Class and Packaging Group: Not regulated
Label(s): N/A
Packing Instruction (Passenger Aircraft): N/A
Packing Instruction (Cargo Aircraft): N/A
Unit Volume: 2 mL
Primary Container Type: 5 mL Plastic, LD polyethylene
Sales Unit: 1 bottle/kit.
15. REGULATORY INFORMATION
SARA 311/312: Hazard categories for SARA Section 311/312 Reporting: Not
Hazardous
Canadian WHMIS Classification: Not a controlled product.
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 4
SAFETY DATA SHEET
5068-RF
16. OTHER INFORMATION
HMIS Hazard Rating 4 Severe Hazard
3 Serious Hazard
HEALTH 1 2 Moderate Hazard
FLAMMABILITY 0 1 Slight Hazard
REACTIVITY 0 0 Minimal Hazard
PERSONAL_PROTECTION B * An asterisk indicates significant chronic health effects
EU Classes and Risk Phrases for Reference (See Sections 2 and 3):
N - Dangerous for the environment
T+ - Very toxic
R28 - Very toxic if swallowed.
R32 - Contact with acids liberates very toxic gas.
R50/53 - Very toxic to aquatic organisms, may cause long-term effects in the aquatic
environment.
If substantial amounts of reagents containing Sodium Azide are disposed of in plumbing
systems, Sodium Azide may build up and form metal azides with copper or lead. This may
produce a potential explosion hazard. See product insert or "Safety Management No. CDC-
22 (United States Center for Disease Control) Decontamination of Laboratory Sink Drains
to remove Azide Salts".
Reason for Revision: Revisions to section(s) 1
Prepared by: Regulatory Affairs Department
The opinions expressed herein are those of qualified experts within Siemens Medical
Solutions Diagnostics. We believe that the information contained herein is current as of the
date of this Material Safety Data Sheet. Since the use of this information and these
opinions and the conditions of use of the product are not within the control of Siemens
Medical Solutions Diagnostics, it is the users' obligation to assure safe use of the product.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 5
SAFETY DATA SHEET
8377GR
Siemens Medical Solutions Diagnostics Emergency Telephone
511 Benedict Avenue 1-800-424-9300 (Chemtrec)
Tarrytown, NY 10591; USA Technical Information
1-877-229-3711
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND
THE COMPANY/UNDERTAKING
Product Name: Hemoglobin A1c Normal Control
Product Number: 8377GR
Date Prepared: 4/1/2007
Revision Number: 4
Recommended Use: In vitro diagnostic reagent
2. COMPOSITION/INFORMATION ON INGREDIENTS
Pursuant to United States OSHA Regulations 29 CFR Part 1910.1200, This Product Is Not
Considered To Contain Hazardous Materials.
(Note: This product does contain material derived from human sources and may be
considered a biohazard and/or Regulated Medical Waste in your state. Check your Local
Environmental Regulations.)
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
3. HAZARDS IDENTIFICATION
Man: None determined.
Environment: None determined.
4. FIRST AID MEASURES
Emergency First Aid Procedures: Call a physician immediately. Arrange for
transport to the nearest ER (emergency room).
While awaiting the physician or transport to the ER:
Inhalation: If it occurs move patient to fresh air. If not breathing, give artificial
respiration. If breathing is difficult, give oxygen.
Ingestion: If the patient is conscious, wash out mouth with water, give one or two glasses
of water or milk to dilute immediately. Transport to hospital for further medical attention.
Skin Contact: Remove any contaminated clothing. Wash off with soap and water. Wash
contaminated clothing before re-use.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 1
SAFETY DATA SHEET
8377GR
Eye Contact: In case of eye contact immediately flush eyes with copious amounts of
water for at least 15-20 minutes. Transport to hospital to see an ophthalmologist.
5. FIRE-FIGHTING MEASURES
Extinguishing Media: Use whatever is required for the surrounding area.
Special Fire Fighting Procedures: It is always best to wear a self-contained
breathing apparatus.
Unusual Fire and Explosion Hazards: None determined.
6. ACCIDENTAL RELEASE MEASURES
Steps to be taken in case material is released or spilled: Wear chemical
resistant rubber gloves and laboratory apron. Sweep up, avoiding dust and place in a
biohazard container. Wipe up area with a damp paper towel and discard in a biohazard
container. Disinfect spill area with a 10% bleach solution.
7. HANDLING AND STORAGE
Store at temperatures and conditions as indicated on the product label. Handle as a human
serum sample. Prevent contact with the eyes, skin and clothing. Do not breathe dust. Wash
hands before breaks and immediately after handling the product.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Ventilation: Use general room ventilation.
Respiratory Equipment: None required.
Protective Gloves: Standard laboratory chemical rubber or latex gloves.
Eye Protection: Standard laboratory safety glasses recommended. Contact lenses
should not be worn in the laboratory.
Other Protective Equipment/Clothing: A laboratory coat or apron is recommended.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance and odor: Reddish-brown lyophilized powder.
pH: N/A
Specific Gravity (H2O=1): N/D
Boiling Point (F): N/A
Melting Point (F): N/D
Vapor Pressure: N/A
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 2
SAFETY DATA SHEET
8377GR
Evaporation Rate: N/A
Solubility in Water: Soluble
Flash Point (Method Used): None
Flammable Limits: LEL: Not Applicable UEL: Not Applicable
N/A = Not Applicable N/D = Not Determined
10. STABILITY AND REACTIVITY
Stability: Stable
Conditions to Avoid: Avoid excessive heat which may cause product decomposition.
Substances to Avoid: None determined.
Hazardous Decomposition Products: Thermal decomposition may yield oxides of
carbon and nitrogen.
Hazardous Polymerization: Will Not Occur
11. TOXICOLOGICAL INFORMATION
Chronic Effects of Overexposure: None currently known.
Carcinogen or Suspected Carcinogen: None of the components are listed as a
carcinogen or suspected carcinogen.
Medical Conditions Aggravated by Exposure: None currently known.
Acute Toxicity:
Inhalation: Inhalation of dust may cause minor respiratory discomfort.
Ingestion: Contains human serum or other human source material. May cause
gastrointestinal irritation and other adverse effects.
Skin Contact: Contact may cause mild irritation.
Eye Contact: May cause mild irritation.
Acute Toxicity Values: Not applicable
12. ECOLOGICAL INFORMATION
Ecological effects of this mixture have not been determined.
13. DISPOSAL CONSIDERATIONS
Primary Container Type: The product container is glass.
Waste Disposal Method: Each disposal facility must determine proper disposal
methods to comply with Local, State and Federal Environmental Regulations.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 3
SAFETY DATA SHEET
8377GR
14. TRANSPORT INFORMATION
Proper Shipping Name: Not regulated
Technical Name:
UN Number: N/A
Hazard Class and Packaging Group: Not regulated
Label(s): N/A
Packing Instruction (Passenger Aircraft): N/A
Packing Instruction (Cargo Aircraft): N/A
Unit Volume: 0.25 mL before lyophilization
Primary Container Type: 1 mL Glass
Sales Unit: 2 Bottles / kit
15. REGULATORY INFORMATION
Canadian WHMIS Classification: Not a controlled product.
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
16. OTHER INFORMATION
HMIS Hazard Rating 4 Severe Hazard
3 Serious Hazard
HEALTH 1 2 Moderate Hazard
FLAMMABILITY 0 1 Slight Hazard
REACTIVITY 0 0 Minimal Hazard
PERSONAL_PROTECTION C * An asterisk indicates significant chronic health effects
WARNING - POSSIBLE HAZARDOUS MATERIAL
Any product prepared from human blood, plasma, or serum should be handled cautiously as
a hazardous material according to good laboratory practices. Each donor unit used in the
preparation of this product was tested by a United States FDA approved method for the
presence of the antibody to HIV as well as for hepatitis B surface antigen and found to be
negative (was not repeatedly reactive). Because no test method can offer complete
assurance that human T-lymphotropic virus types III (HIV), hepatitis B virus, or other
infectious agents are absent, this product should be handled at the Biosafety Level 2 as
recommended for any potentially infectious human serum or blood specimen in the United
States Centers for Disease Control/National Institutes of Health manual "Biosafety in
Microbiological and Biomedical Laboratories," 1984.
Reason for Revision: Revisions to section(s) 1
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 4
SAFETY DATA SHEET
8377GR
Prepared by: Regulatory Affairs Department
The opinions expressed herein are those of qualified experts within Siemens Medical
Solutions Diagnostics. We believe that the information contained herein is current as of the
date of this Material Safety Data Sheet. Since the use of this information and these
opinions and the conditions of use of the product are not within the control of Siemens
Medical Solutions Diagnostics, it is the users' obligation to assure safe use of the product.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 5
SAFETY DATA SHEET
8378GR
Siemens Medical Solutions Diagnostics Emergency Telephone
511 Benedict Avenue 1-800-424-9300 (Chemtrec)
Tarrytown, NY 10591; USA Technical Information
1-877-229-3711
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND
THE COMPANY/UNDERTAKING
Product Name: Hemoglobin A1c Abnormal Control
Product Number: 8378GR
Date Prepared: 4/1/2007
Revision Number: 4
Recommended Use: In vitro diagnostic reagent
2. COMPOSITION/INFORMATION ON INGREDIENTS
Pursuant to United States OSHA Regulations 29 CFR Part 1910.1200, This Product Is Not
Considered To Contain Hazardous Materials.
(Note: This product does contain material derived from human sources and may be
considered a biohazard and/or Regulated Medical Waste in your state. Check your Local
Environmental Regulations.)
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
3. HAZARDS IDENTIFICATION
Man: None determined.
Environment: None determined.
4. FIRST AID MEASURES
Emergency First Aid Procedures: Call a physician immediately. Arrange for
transport to the nearest ER (emergency room).
While awaiting the physician or transport to the ER:
Inhalation: If it occurs move patient to fresh air. If not breathing, give artificial
respiration. If breathing is difficult, give oxygen.
Ingestion: If the patient is conscious, wash out mouth with water, give one or two glasses
of water or milk to dilute immediately. Transport to hospital for further medical attention.
Skin Contact: Remove any contaminated clothing. Wash off with soap and water. Wash
contaminated clothing before re-use.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 1
SAFETY DATA SHEET
8378GR
Eye Contact: In case of eye contact immediately flush eyes with copious amounts of
water for at least 15-20 minutes. Transport to hospital to see an ophthalmologist.
5. FIRE-FIGHTING MEASURES
Extinguishing Media: Use whatever is required for the surrounding area.
Special Fire Fighting Procedures: It is always best to wear a self-contained
breathing apparatus.
Unusual Fire and Explosion Hazards: None determined.
6. ACCIDENTAL RELEASE MEASURES
Steps to be taken in case material is released or spilled: Wear chemical
resistant rubber gloves and laboratory apron. Sweep up, avoiding dust and place in a
biohazard container. Wipe up area with a damp paper towel and discard in a biohazard
container. Disinfect spill area with a 10% bleach solution.
7. HANDLING AND STORAGE
Store at temperatures and conditions as indicated on the product label. Handle as a human
serum sample. Prevent contact with the eyes, skin and clothing. Do not breathe dust. Wash
hands before breaks and immediately after handling the product.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Ventilation: Use general room ventilation.
Respiratory Equipment: None required.
Protective Gloves: Standard laboratory chemical rubber or latex gloves.
Eye Protection: Standard laboratory safety glasses recommended. Contact lenses
should not be worn in the laboratory.
Other Protective Equipment/Clothing: A laboratory coat or apron is recommended.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance and odor: Reddish-brown lyophilized powder.
pH: N/A
Specific Gravity (H2O=1): N/D
Boiling Point (F): N/A
Melting Point (F): N/D
Vapor Pressure: N/A
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 2
SAFETY DATA SHEET
8378GR
Evaporation Rate: N/A
Solubility in Water: Soluble
Flash Point (Method Used): None
Flammable Limits: LEL: Not Applicable UEL: Not Applicable
N/A = Not Applicable N/D = Not Determined
10. STABILITY AND REACTIVITY
Stability: Stable
Conditions to Avoid: Avoid excessive heat which may cause product decomposition.
Substances to Avoid: None determined.
Hazardous Decomposition Products: Thermal decomposition may yield oxides of
carbon and nitrogen.
Hazardous Polymerization: Will Not Occur
11. TOXICOLOGICAL INFORMATION
Chronic Effects of Overexposure: None currently known.
Carcinogen or Suspected Carcinogen: None of the components are listed as a
carcinogen or suspected carcinogen.
Medical Conditions Aggravated by Exposure: None currently known.
Acute Toxicity:
Inhalation: Inhalation of dust may cause minor respiratory discomfort.
Ingestion: Contains human serum or other human source material. May cause
gastrointestinal irritation and other adverse effects.
Skin Contact: Contact may cause mild irritation.
Eye Contact: May cause mild irritation.
Acute Toxicity Values: Not applicable
12. ECOLOGICAL INFORMATION
Ecological effects of this mixture have not been determined.
13. DISPOSAL CONSIDERATIONS
Primary Container Type: The product container is LD Polyethylene.
Waste Disposal Method: Each disposal facility must determine proper disposal
methods to comply with Local, State and Federal Environmental Regulations.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 3
SAFETY DATA SHEET
8378GR
14. TRANSPORT INFORMATION
Proper Shipping Name: Not regulated
Technical Name:
UN Number: N/A
Hazard Class and Packaging Group: Not regulated
Label(s): N/A
Packing Instruction (Passenger Aircraft): N/A
Packing Instruction (Cargo Aircraft): N/A
Unit Volume: 0.25 mL before lyophilization
Primary Container Type: 1 mL Plastic, LD polyethylene
Sales Unit: 2 Bottles / kit
15. REGULATORY INFORMATION
Canadian WHMIS Classification: Not a controlled product.
EU Classification (1999/45/EC): Not applicable
EU Risk and Safety Phrases: None
16. OTHER INFORMATION
HMIS Hazard Rating 4 Severe Hazard
3 Serious Hazard
HEALTH 1 2 Moderate Hazard
FLAMMABILITY 0 1 Slight Hazard
REACTIVITY 0 0 Minimal Hazard
PERSONAL_PROTECTION C * An asterisk indicates significant chronic health effects
WARNING - POSSIBLE HAZARDOUS MATERIAL
Any product prepared from human blood, plasma, or serum should be handled cautiously as
a hazardous material according to good laboratory practices. Each donor unit used in the
preparation of this product was tested by a United States FDA approved method for the
presence of the antibody to HIV as well as for hepatitis B surface antigen and found to be
negative (was not repeatedly reactive). Because no test method can offer complete
assurance that human T-lymphotropic virus types III (HIV), hepatitis B virus, or other
infectious agents are absent, this product should be handled at the Biosafety Level 2 as
recommended for any potentially infectious human serum or blood specimen in the United
States Centers for Disease Control/National Institutes of Health manual "Biosafety in
Microbiological and Biomedical Laboratories," 1984.
Reason for Revision: Revisions to section(s) 1
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 4
SAFETY DATA SHEET
8378GR
Prepared by: Regulatory Affairs Department
The opinions expressed herein are those of qualified experts within Siemens Medical
Solutions Diagnostics. We believe that the information contained herein is current as of the
date of this Material Safety Data Sheet. Since the use of this information and these
opinions and the conditions of use of the product are not within the control of Siemens
Medical Solutions Diagnostics, it is the users' obligation to assure safe use of the product.
Regulated by: OSHA 29 CFR 1910.1200, USA / EC Directive 5
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