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					Abbott Diagnostics 100 Abbott Park Road Abbott Park, IL 60064 Release Date: 12/15/06

ADD List Number Product Name 2223-20 Components: 2223G 2223H 90273 2223J 2223Q
1 No

IMx FSH Reagent Pack IMx FSH Coated Microparticles1 IMx FSH Alkaline Phosphatase Conjugate IMx Substrate Buffer 4-Methylumbelliferyl Phosphate (MUP) 1 IMx FSH Wash Buffer IMx FSH Mode 1 Calibrator1

MSDS issued. Per OSHA 29 CFR 1910.1200, Material Safety Data Sheets are required only for products containing hazardous ingredients at a concentration equal to or greater than 1% and/or carcinogens at a concentration equal to or greater than 0.1%.

Scroll down to display the MSDS as applicable.
Abbott Customers: For additional information, please contact your Abbott Customer Support Center Representative by calling 1-800-527-1869, 1-800-323-9100, or 1-800-235-5396. Abbott employees: For additional information relative to the content of the MSDSs, please contact your local Safety Representative.

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Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

1 Identification of Substance · Product name: IMx FSH Alkaline Phosphatase Conjugate · ADD List number: 2223H · Manufacturer / Supplier: Abbott Diagnostics 100 Abbott Park Road Abbott Park, IL 60064-3500 · Department issuing MSDS: Abbott Diagnostics Safety, Health and Environmental Assurance 2 Composition / Information on Ingredients · Chemical characterization: Mixture of chemical and/or biological substances for in vitro diagnostic use. · Hazardous ingredients per OSHA criteria: 9002-92-0 Brij 35 1185-53-1 Tromethamine hydrochloride *

2.91% 1.14%

3 Hazards Identification / Emergency Overview · Routes of Exposure: Inhalation · Classification system: The classification was made according to OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European Community Directives, and is expanded upon from company and/or literature data. · National Fire Protection Association (NFPA) ratings (scale 0-4) Health = 0 Fire = 0 Reactivity = 0 · Hazard Overview · Health: Minimal risk if used as directed · Fire: Noncombustible · Reactivity: Minimal Risk · Special Hazards: None · Carcinogenicity information · OSHA (Occupational Safety and Health Administration) None of the ingredients is listed. · NTP (National Toxicology Program) None of the ingredients is listed. · IARC (International Agency for Research on Cancer) None of the ingredients is listed. 4 First Aid Measures · After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention. · After skin contact: Wash effected area with soap and water. If irritation or signs of toxicity occur, seek medical attention. · After eye contact: Flush with copious amounts of water. If irritation or signs of toxicity occur, seek medical attention. · After swallowing: If irritation or signs of toxicity occur, seek medical attention. · Information for medical personnel: · The following symptoms may occur: Kidney effects · Medical conditions aggravated by exposure: Pre-existing renal ailments 5 Fire Fighting Measures · Suitable extinguishing agents: Dry Chemical, CO2, water spray or, regular foam. Fight larger fires with water spray, fog, or regular foam.
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Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

Product name: IMx FSH Alkaline Phosphatase Conjugate · Protective equipment: For large fires, wear appropriate heat and flame resistant personal protective equipment and a NIOSH/MSHA approved positive pressure, self contained breathing apparatus. 6 Accidental Release Measures · Safe work practices: If material is released or spilled, minimize exposure by using appropriate personal protective equipment as listed in section 8. If possible, stop leak. Keep unprotected persons away. · Measures for environmental protection: Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil. · Measures for cleaning / collecting: Absorb with liquid-binding materials such as sand, diatomite, acid binders, or sawdust. Wash spill area with appropriate cleaning materials. Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. 7 Handling and Storage · Information for safe handling: Avoid direct contact with material and wash after handling. Practice general safety precautions. · Information about protection against explosions and fires: No special measures required. · Requirements to be met by storerooms and receptacles: Refer to the package insert or product label for additional information on storage conditions. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Protect from heat and direct sunlight. * 8 Exposure Controls and Personal Protection · Components with Occupational Exposure Limits 26628-22-8 sodium azide (0.10%) REL STEL/C: C 0.3** mg/m³, C 0.1* ppm *as HN3 vapor; **as NaN3; Skin TLV STEL/C: C 0.29** mg/m³, C 0.11* ppm *as HN3 vapor **as NaN3 7646-85-7 zinc chloride (0.001%) PEL 1 mg/m³ Fume REL STEL/C: 2 mg/m³ TWA: 1 mg/m³ TLV STEL/C: 2 mg/m³ TWA: 1 mg/m³ fume · General protective and hygienic measures: Always maintain good housekeeping. Do not eat, drink or store food and beverages in areas where chemicals are used. Wash hands before breaks and at the end of the workshift. · Breathing equipment: Not necessary if room is well-ventilated. Use appropriate NIOSH/MSHA air purifying respirator if airborne chemical concentrations exceed the exposure limit (if any) listed above. · Hand protection: Wear impervious gloves if hand contact with the material is anticipated. · Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles. · Body protection: Wear laboratory coat or appropriate protective clothing when working with material. 9 Physical and Chemical Properties · Form: Liquid
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Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

Product name: IMx FSH Alkaline Phosphatase Conjugate · Color: Colorless · Odor: Odorless · Boiling point/Boiling range: Not determined · Flash point: Not applicable · Auto igniting: Product is not self-igniting. · Danger of explosion: Product does not present an explosion hazard. · Density: Not determined · Solubility in / Miscibility with Fully miscible Water: · pH-value at 20°C (68°F): 7.1 · Water: 90.0 % 10 Stability and Reactivity · Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. · Dangerous reactions: Reactions with heavy metals may form explosive substances. Contact with acids may release toxic gas (such as, hydrazoic acid HN3). · Dangerous products of decomposition: No dangerous decomposition products known. 11 Toxicological Information · LD50/LC50 values for hazardous ingredients per OSHA criteria: · Ingredients (100% pure substance/s) 9002-92-0 Brij 35 Oral LD50 384 mg/kg (guinea pig) > 1000 mg/kg (mouse) 1000 mg/kg (rat) 1185-53-1 Tromethamine hydrochloride Oral LD50 <1000 mg/kg (rabbit) 1780 - 5900 mg/kg (rat) · Primary toxicological effects of the final product: · Skin irritation: No irritant effect. · Eye irritation: No irritant effect. · Sensitization: No sensitizing effects known. · Target organs/systems: Kidneys * 12 Ecological Information · General notes: Do not allow undiluted product or large quantities of it to reach ground water, water course, or sewage system. 13 Disposal Considerations · Recommendation for disposal of unused product: Dispose in accordance with Federal, State and Local regulations. · Recommendation for disposal of packaging: Dispose in accordance with Federal, State and Local regulations. · Recommended cleansing agent: Water, if necessary with cleansing agents. 14 Transport Information · Road: DOT class · Remarks: · Sea: IMDG Class · Marine pollutant: · Remarks:

Not restricted for transportation. No Not restricted for transportation.
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Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

Product name: IMx FSH Alkaline Phosphatase Conjugate · Air: ICAO/IATA Class · Remarks: Not restricted for transportation. * 15 National and International Regulations · SARA (Superfund Amendments and Reauthorization Act of 1986 - USA): · Section 302/304 (40CFR355.30 / 40CFR355.40): 26628-22-8 sodium azide · Section 313 (40CFR372.65): 26628-22-8 sodium azide · California Proposition 65 (USA): · Chemicals known to cause cancer: The product does not contain listed substances. · Chemicals known to cause female reproductive toxicity: None of the ingredients is listed. · Chemicals known to cause male reproductive toxicity: None of the ingredients is listed. · Chemicals known to cause developmental reproductive toxicity: None of the ingredients is listed. · Markings according to European guidelines: The product has been classified and labeled in accordance with applicable European Community (EC) Directives. · Hazard designation of product: Xn Harmful · Hazard determining substance/s of labeling: sodium azide · Risk phrases: 22 Harmful if swallowed. 32 Contact with acids liberates very toxic gas. · Safety phrases: 35 This material and its container must be disposed of in a safe way. 36 Wear suitable protective clothing. 46 If swallowed, seek medical advice immediately and show this container or label. 16 Other Information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. · Contact: - general information: Abbott Diagnostics Safety, Health and Environmental Assurance Department 03A4 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: 847-937-3386 - 24 hour EMERGENCY PHONE: 847-937-7970 · * Sections marked with an asterisk (*) have been altered since the previous version.
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Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

1 Identification of Substance · Product name: IMx FSH Wash Buffer · ADD List number: 2223J · Manufacturer / Supplier: Abbott Diagnostics 100 Abbott Park Road Abbott Park, IL 60064-3500 · Department issuing MSDS: Abbott Diagnostics Safety, Health and Environmental Assurance 2 Composition / Information on Ingredients · Chemical characterization: Mixture of chemical and/or biological substances for in vitro diagnostic use. · Hazardous ingredients per OSHA criteria: 10377-48-7 lithium sulfate *

1.02%

3 Hazards Identification / Emergency Overview · Routes of Exposure: None anticipated, when used as directed. · Classification system: The classification was made according to OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European Community Directives, and is expanded upon from company and/or literature data. · National Fire Protection Association (NFPA) ratings (scale 0-4) Health = 0 Fire = 0 Reactivity = 0 · Hazard Overview · Health: Minimal risk if used as directed · Fire: Noncombustible · Reactivity: Minimal Risk · Special Hazards: None · Carcinogenicity information · OSHA (Occupational Safety and Health Administration) None of the ingredients is listed. · NTP (National Toxicology Program) None of the ingredients is listed. · IARC (International Agency for Research on Cancer) None of the ingredients is listed. 4 First Aid Measures · After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention. · After skin contact: Wash effected area with soap and water. If irritation or signs of toxicity occur, seek medical attention. · After eye contact: Flush with copious amounts of water. If irritation or signs of toxicity occur, seek medical attention. · After swallowing: If irritation or signs of toxicity occur, seek medical attention. · Information for medical personnel: · The following symptoms may occur: Kidney effects Cramps Gastric or intestinal disorders Nausea Headache Dizziness Disorientation Possibly thyroid response
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Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

Product name: IMx FSH Wash Buffer · Medical conditions aggravated by exposure: Pre-existing renal ailments Pre-existing gastrointestinal tract ailments Pre-existing nervous system ailments Pre-existing thyroid ailments 5 Fire Fighting Measures · Suitable extinguishing agents: Dry Chemical, CO2, water spray or, regular foam. Fight larger fires with water spray, fog, or regular foam. · Protective equipment: For large fires, wear appropriate heat and flame resistant personal protective equipment and a NIOSH/MSHA approved positive pressure, self contained breathing apparatus. 6 Accidental Release Measures · Safe work practices: If material is released or spilled, minimize exposure by using appropriate personal protective equipment as listed in section 8. If possible, stop leak. Keep unprotected persons away. · Measures for environmental protection: No special measures required. · Measures for cleaning / collecting: Absorb with liquid-binding materials such as sand, diatomite, acid binders, or sawdust. Wash spill area with appropriate cleaning materials. Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. 7 Handling and Storage · Information for safe handling: Avoid direct contact with material and wash after handling. Practice general safety precautions. · Information about protection against explosions and fires: No special measures required. · Requirements to be met by storerooms and receptacles: Refer to the package insert or product label for additional information on storage conditions. · Information about storage in one common storage facility: Store in original packaging. · Further information about storage conditions: Protect from heat and direct sunlight. 8 Exposure Controls and Personal Protection · Components with Occupational Exposure Limits The product does not contain any hazardous ingredients with occupational exposure limits established by OSHA, ACGIH, or NIOSH. · General protective and hygienic measures: Always maintain good housekeeping. Do not eat, drink or store food and beverages in areas where chemicals are used. Wash hands before breaks and at the end of the workshift. · Breathing equipment: Not necessary if room is well-ventilated. Use appropriate NIOSH/MSHA air purifying respirator if airborne chemical concentrations exceed the exposure limit (if any) listed above. · Hand protection: Wear impervious gloves if hand contact with the material is anticipated. · Eye protection: Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles. · Body protection: Wear laboratory coat or appropriate protective clothing when working with material. 9 Physical and Chemical Properties · Form: Liquid · Color: Colorless · Odor: Odorless
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Page 3/4

Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

Product name: IMx FSH Wash Buffer · Boiling point/Boiling range: Not determined · Flash point: Not applicable · Auto igniting: Product is not self-igniting. · Danger of explosion: Product does not present an explosion hazard. · Density: Not determined · Solubility in / Miscibility with Fully miscible Water: · pH-value at 20°C (68°F): 7.5 · Water: 98.1 % 10 Stability and Reactivity · Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. · Dangerous reactions: No dangerous reactions known. · Dangerous products of decomposition: No dangerous decomposition products known. 11 Toxicological Information · LD50/LC50 values for hazardous ingredients per OSHA criteria: · Ingredients (100% pure substance/s) 10377-48-7 lithium sulfate Oral LD50 1190 mg/kg (mouse) Dermal LD50 953 mg/kg (mouse) Target Organ Effects clinical (human) Large doses of lithium ion have caused dizziness, prostration, and caused kidney damage if sodium intake is limited. Dehydration, weight loss and thyroid disturbances have been reported. Central nervous system effects, including slurred speech, blurred vision, sensory loss, ataxia and convulsions have been reported. · Primary toxicological effects of the final product: · Skin irritation: No irritant effect. · Eye irritation: No irritant effect. · Sensitization: No sensitizing effects known. · Target organs/systems: Kidneys Gastrointestinal tract Nervous system Thyroid * 12 Ecological Information · General notes: Not known to be a water pollutant. 13 Disposal Considerations · Recommendation for disposal of unused product: Dispose in accordance with Federal, State and Local regulations. · Recommendation for disposal of packaging: Dispose in accordance with Federal, State and Local regulations. · Recommended cleansing agent: Water, if necessary with cleansing agents. 14 Transport Information · Road: DOT class · Remarks: · Sea: IMDG Class · Marine pollutant:

Not restricted for transportation. No
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Page 4/4

Material Safety Data Sheet
Release date 12/15/2006 Last alteration on 12/15/2006

Product name: IMx FSH Wash Buffer · Remarks: Not restricted for transportation. · Air: ICAO/IATA Class · Remarks: Not restricted for transportation. * 15 National and International Regulations · SARA (Superfund Amendments and Reauthorization Act of 1986 - USA): · Section 302/304 (40CFR355.30 / 40CFR355.40): The product does not contain listed substances. · Section 313 (40CFR372.65): The product does not contain listed substances. · California Proposition 65 (USA): · Chemicals known to cause cancer: The product does not contain listed substances. · Chemicals known to cause female reproductive toxicity: None of the ingredients is listed. · Chemicals known to cause male reproductive toxicity: None of the ingredients is listed. · Chemicals known to cause developmental reproductive toxicity: None of the ingredients is listed. · Markings according to European guidelines: Observe the general safety regulations when handling chemicals. The product does not require any hazard warnings according to respective European Community (EC) Directives. 16 Other Information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. · Contact: - general information: Abbott Diagnostics Safety, Health and Environmental Assurance Department 03A4 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: 847-937-3386 - 24 hour EMERGENCY PHONE: 847-937-7970 · * Sections marked with an asterisk (*) have been altered since the previous version.
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