Reagent - Biokit

BIOKIT S.A.08186 Llissà d'Amunt(Barcelona) SpainPhone: (34) 93 860 9000Fax: (34) 93 860 9029e-mail: biokit@biokit.comSAFETY DATA SHEETCode: 3000-1158 / 3000-1159Date: 02-01-08 Rev.: 02Pag.: 1 of 31. Identification of preparationProduct name: bioelisa HBsAg 3.02. Composition/information on ingredientsKit components:Microtiter plate: Polystyrene wells coated with guinea pig anti-HBs antibodies.Concentrate conjugate: Goat anti-HBs antibodies conjugated with peroxidase. Contains red dye, proteinstabilisers, 0.02% Bronidox and 0.001% gentamycin sulphate.Conjugate diluent: Tris buffer containing yellow dye, additives, 0.02% Bronidox and 0.001% gentamycinsulphate.Positive control: Normal human serum diluted in phosphate buffer containing purified and inactivated HBsAgand sodium azide 0.02%. Contains green dye.Negative control: HBsAg negative human serum diluted in phosphate buffer containing sodium azide 0.02%.Contains yellow dye.Washing solution: Concentrated phosphate buffer containing 1% Tween 20 and 0.01% thimerosal.Substrate buffer: Citrate-acetate buffer containing hydrogen peroxide.Chromogen: 3,3',5,5'-Tetramethylbenzidine dissolved in dimethylsulphoxide. Contains red dye.Stopping solution: 1 N Sulphuric acid.3. Hazards identificationPositive and negative controls contain less than 0.1% wt of Sodium Azide (NaN 3 ) as preservative.CAS-Nº: 26628-22-8 EINECS-Nº: 247-852-1Washing solution contain less than 0.01% wt of thimerosalCAS-Nº: 54-64-8 EINECS-Nº: 200-210-4Preparation not classified as dangerous according to Directive 1999/45/EC.4. First aid measuresInhalation: Remove from exposure. If breathing is difficult, obtain medical attention if necessary.Eye contact: Rinse immediately with water for at least 15 minutes separating eyelid.Skin contact: Wash off thoroughly with plenty of water. Remove and wash contaminated clothing.Ingestion: Obtain medical attention5. Fire-fighting measuresExtinguishing media: Use media in adaptation to materials stored in the immediate neighbourhood.Special firefighting procedures: Wear self-contained breathing apparatus and protective clothing to prevent contact withskin and eyes.6. Accidental release measuresAfter spillage: Wipe up spills with inert absorbant tissues and place in a suitable container. Use protective gloves.7. Handling and storageHandling: The normal precautions for handling chemicals must be observed. Wash hands after handling.Storage: Between +2ºC to 8ºC.

BIOKIT S.A.08186 Llissà d'Amunt(Barcelona) SpainPhone: (34) 93 860 9000Fax: (34) 93 860 9029e-mail: biokit@biokit.comSAFETY DATA SHEETCode: 3000-1158 / 3000-1159Date: 02-01-08 Rev.: 02Pag.: 2 of 38. Exposure controls/personal protectionRespiratory protection: Good local ventilation.Eye protection: Protective glasses.Hand protection: One-way gloves (latex or plastic).Use protective lab coat. Is recommended the use of safety pipette device.9. Physical and chemical propertiesAppearance:Microtiter plate: solid polystyrene plasticConcentrate conjugate: intense red liquidConjugate diluent: yellow liquidPositive control: green liquidNegative control: yellow liquidWashing solution: colourless liquidSubstrate buffer: colourless liquidChromogen: red liquid.Stopping solution: colourless liquidOdour: OdourlessBoiling point: N/AMelting point: 18ºC for DimethylsulphoxideFlash point: N/AIgnition temperature: N/AExplosion limits: N/AVapour pressure: N/ADensity: N/AViscosity: N/ASolubility in water: soluble10. Stability and reactivityStability:Stable under recommended storage conditions.Conditions to avoid: High temperatures.Materials to avoid: Strong oxidicing agents.Hazardous reactions: Positive and negative controls in this kit contain less than 0.1% wt of sodium azide as apreservative. Sodium azide has been reported to form lead or copper azide in laboratoryplumbing which may explode on percusion. Use proper disposal procedures.Hazardous descomposition products:Data not available on the product it self.11. Toxicological informationData not available.12. Ecological informationData not available.13. Disposal considerationsRemains of samples, reagents and controls should be collected in a recipient for this purpose and autoclaved 1 hour at121ºC.Observe all Federal, State and local laws.14. Transport informationSpecials requirements: None

BIOKIT S.A.08186 Llissà d'Amunt(Barcelona) SpainPhone: (34) 93 860 9000Fax: (34) 93 860 9029e-mail: biokit@biokit.comSAFETY DATA SHEETCode: 3000-1158 / 3000-1159Date: 02-01-08 Rev.: 02Pag.: 3 of 315. Regulatory informationAccording to 1999/45/EC Directive and 91/155/EEC Directive and following modifications.16. Other informationIntended use: ELISA test for the detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma in clinicallaboratories and as a first-line screening assay in blood centres.For IN VITRO diagnostic use.Each donor unit used in the preparation of the controls of this kit was tested by an approved method for the presence ofthe antibodies to HIV and HCV as well as for HBsAg and found to be negative. WARNING: Because no test method canoffer complete assurance that HIV, HCV, HBsAg or other infectious agents are absent, the controls of this kit should behandled carefully.The above information is believed to be correct, but does not purpose to be all inclusive and should be used only as aguide. BIOKIT S.A. shall not be held for any damage resulting from handling or use of the product.