SAFETY DATA SHEET PAGE 1 OF 6

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1 SAFETY DATA SHEET PAGE 1 OF 6 1. IDENTIFICATION This Safety Data Sheet is for the following products: MANUFACTURER: Immucor GTI Diagnostics, Inc Crossroads Circle Waukesha WI USA Manufacturer s Phone: 855-IMMUCOR ( ) AUTHORIZED REPRESENTATIVE: Immucor Medizinische Diagnostik GmbH Robert-Bosch-Strasse Dreieich Germany After normal business hours, weekends, and holidays: Call your local emergency center. Chemical Emergency Spill Leak Fire Exposure or Accident call CHEMTREC Domestic North America: International: (collect calls accepted) Product Name: Pak Lx TM Assay Catalog Number REF : PLX Kit Components Size Lyophilized Bead Blend 3 vials Bead Diluent 1 x 850 µl Conjugate Concentrate 1 x 120 µl Conjugate Diluent 1 x 1.2 ml Wash Buffer 1 x 50 ml Positive Control Serum 1 x 80 µl Negative Control Serum 1 x 80 µl SPECIFIC USE: For In Vitro Diagnostic Use IVD 2. HAZARDS IDENTIFICATION 2.1 Classification of the substance or mixture: Bead Diluent (0.05% ProClin 300) (*) ProClin 300 contains a dangerous ingredient: mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H-isothiazol-3- one at a concentration between 2.8 and 3.8%. In the column classification substance, the classification of this ingredient is mentioned. 2.2 Label elements: Bead Diluent Hazard pictogram: Signal Word: Warning GHS07 H317 May cause an allergic skin reaction P261 Avoid breathing dust/fume/gas/mist/vapours/spray P272 Contaminated work clothing should not be allowed out of the workplace P280 Wear protective gloves/protective clothing/eye protection/face protection

2 SAFETY DATA SHEET PAGE 2 OF 6 P302 + P352: IF ON SKIN: Wash with plenty of soap and water. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P501 Dispose of contents/container to an approved waste disposal plant. 3. COMPOSITION/INFORMATION ON INGREDIENTS Kit Components Hazardous Ingredients CAS Classification Concentration NUMBER Bead Diluent 0.05% ProClin (*) (*) ProClin 300 contains a dangerous ingredient: mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H-isothiazol-3-one at a concentration between 2.8 and 3.8%. In the column classification substance, the classification of this ingredient is mentioned. 4. FIRST AID MEASURES All kit components Eye contact Rinse immediately with plenty of water for 15 minutes. Assure adequate flushing by separating the eyelids with fingers. Do not apply neutralizing agents Consult a doctor/medical service if irritation persists Skin contact Immediately wash skin with soap and copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes Consult a doctor/medical service if irritation persists After inhalation Remove the victim into fresh air Unconscious: maintain adequate airway and respiration If not breathing give artificial respiration If breathing is difficult, give oxygen Consult a doctor/medical service if breathing problems develop After ingestion Wash out mouth with water provided person is conscious Never give water to an unconscious person Do not induce vomitting Consult a doctor/medical service if you feel unwell 5. FIRE-FIGHTING MEASURES Suitable extinguishing media: Unsuitable extinguishing media: Special exposure hazards: Special protective equipment for firefighters: Specific methods for firefighting: Carbon dioxide, dry chemical powder, or appropriate foam Emits toxic fumes under fire conditions Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes Do not direct a solid stream of water at burning materials as spattering may result. 6. ACCIDENTAL RELEASE MEASURES Personal Protection: See Section 8 Clean up: - Take up liquid spill into absorbent material and place in closed containers for disposal - Discharge of absorbed material according to local regulations - Clean contaminated surfaces with an excess of water - Wash clothing and equipment after handling Environmental precautions: - Prevent soil and water pollution - Discharge according to local regulations

3 SAFETY DATA SHEET PAGE 3 OF 6 7. HANDLING AND STORAGE Handling: Storage: -Observe normal hygiene standards -Discharge according to local regulations -Remove and clean contaminated clothing -Handle and open the container with care -Keep container tightly closed -Meet the legal requirements -Keep away from: heat sources, combustible materials, acids, and metals -Storage temperature: see component label 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Personal Protection Eye protection: Hand protection: Suitable materials: Skin protection: Respiratory protection: Safety glasses Face shield Gloves Butyl rubber, natural rubber, neoprene, nitrile rubber, polyethylene Protective clothing NA 9. PHYSICAL AND CHEMICAL PROPERTIES (a) Appearance (physical state, color, etc.); Lyophilized Bead Blend Lyophilized Beads Bead Diluent Blue Conjugate Concentrate Light pink Conjugate Diluent, Wash Buffer Clear Positive Serum Control, Negative Serum Control Pale yellow to clear (b) Odor; (c) Odor threshold; (d) ph; (e) Melting point/freezing point; (f) Initial boiling point and boiling range; (g) Flash point; (h) Evaporation rate; (i) Flammability (solid, gas); (j) Upper/lower flammability or explosive limits; (k) Vapor pressure; (l) Vapor density; None None various

4 SAFETY DATA SHEET PAGE 4 OF 6 (m) Relative density; (n) Solubility(ies); (o) Partition coefficient: n-octanol/water; (p) Auto-ignition temperature; (q) Decomposition temperature; (r) Viscosity. 10. STABILITY AND REACTIVITY Stability: Reactivity/Hazardous decomposition products: Conditions/Materials to avoid: All components are stable until expiry date if stored in specified conditions (see label) No hazardous decomposition products are formed in high quantities Keep away from metals and acids (Azide containing components) 11. TOXICOLOGICAL INFORMATION See 3. Composition/Information on ingredients to identify the kit components that contain the substances mentioned in this section Acute toxicity: Components containing ProClin 300 Irritation Data Components containing ProClin 300 Sensitization Skin Signs and Symptoms of Exposure LD50 Oral rat, female 3,723 mg/kg LD50 Oral rat, male 3,600 mg/kg LD50 Skin Rabbit > 3,600 mg/kg LD50 Skin Rabbit 3,500 mg/kg Skin Rabbit 18.6 % Remarks: Severe irritation effect Skin Rabbit 9.3 % Remarks: Moderate irritation effect Skin Rabbit 1.8 % Remarks: No irritation effect Eyes Rabbit Remarks: Severe irritation effect Eyes Rabbit 9.3 % Remarks: Moderate irritation effect Eyes 1.8 % Remarks: No irritation effect Eyes Rabbit Remarks: Severe irritation effect Skin Rabbit Remarks: Severe irritation effect May cause allergic skin reaction Exposure can cause: Dermatitis. To the best of our knowledge, the chemical, physical, and toxicological properties have not b een thoroughly investigated. Material is extremely destructive to tissue of the mucous membranes and upper respiratory tract, eyes, and skin. Inhalation may result in spasm, inflammation and edema of the larynxand bronchi, chemical pneumonitis, and pulmonary ed ema. Symptoms of exposure may include burning sensation, coughing, wheezing, laryngitis, shortness of breath, headache, nausea, and vomiting. Routes of exposure: Skin Contact: Causes burns. Skin Absorption: Harmful if absorbed through skin. Eye Contact: Causes burns. Inhalation: Harmful if inhaled. Material is extremely destructive to the tissue of the mucous membranes and upper respiratory tract. Ingestion: Harmful if swallowed.

5 SAFETY DATA SHEET PAGE 5 OF ECOLOGICAL INFORMATION Aquatic toxicity NA Other information - WGK: 1 (Classification based on the components as per Verwaltungsvorschrift wassergefährdender Stoffe (VwVwS) of 17 May 1999) - Effect on the ozone layer: Not dangerous for the ozone layer (1999/45/EC) - Greenhouse effect: - Effect on waste water purification: 13. DISPOSAL CONSIDERATIONS Dispose in accordance with applicable federal, state, and local government regulations. Waste generators must determine wheth er a discarded material is classified as a hazardous waste. USEPA guidelines for the classification determination are listed in 40 CFR parts Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurat e classification. Provisions relating to waste: Hazardous waste (91/689/EEC) Packaging/container: - Waste material code packaging (91/689/EEC, Council Decision 2001/118/EC, O.J. L47 of 16/2/2001): (packaging containing residues of or contaminated by dangerous substances) Disposal methods: - Patient samples, Bead Diluent, Positive Serum Control, Negative Serum Control, Bead Blend, Conjugate Concentrate and Wash Buffer are potentially infectious. They should be disposed of following established safety procedures and local regulations. - All the kit components must be considered as hazardous waste. They should be disposed of following local regulations. 14. TRANSPORT INFORMATION No Restrictions 15. REGULATORY INFORMATION TSCA: All components of this product besides Pro Clin 300 are listed on the TSCA inventory. CERCLA Reportable Quantity: None Clean Air Amendments-Hazardous Air Pollutant (HAPS): None SARA Title III Section 302: None SARA Title III Section 313: None SARA Title III Section 311/312 None 16. OTHER INFORMATION This product is designed for use by professionals. Reagents made with human source material have been tested by FDA approved methods and found negative for HBsAg, anti-hcv and anti-hiv-1/2. No known method can offer complete assurance that human blood derivatives will not transmit hepatitis, AIDS or other infections. Therefore, handling of reagents, serum or plasma specimens should be in accordance with local safety procedures. All animal products and derivatives have been collected from healthy animals. Bovine components originate from countries where BSE has not been reported. The information provided on this SDS is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered as a warranty or quality specification.

6 SAFETY DATA SHEET PAGE 6 OF 6 The information relates only to the specific material designated and may not be valid for such material used in c ombination with any other material or in any process, unless specified in the text. DISCLAIMER: The information contained herein is based on data considered accurate and is offered at no charge. No warranty is expressed or implied regarding the accuracy of this data. Liability is expressly disclaimed for loss or injury arising out of use of this information or the use of any materials designated. It remains the user s own responsibility to make sure that the information is appropriate and complete for h is specific use of this product. The user is also responsible for observing any laws and applicable guidelines. Based on Regulation 1907/2006 (REACH) REVISION DATE: