Quidel Triage BNP Calibrators

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Official CopyApproved for UseSDS-98202T-ENRevision: 1Revision/Effective Date: 02 May 2018Quidel Triage BNP CalibratorsSafety Data Sheet SDS-98202T-ENaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations and Regulation (EC)No. 1907/2006 (REACH) with its amendment Regulation (EU) 2015/830Revision: 1SECTION 1: Identification of the substance/mixture and of the company/undertaking1.1.Product identifierProduct form:MixtureProduct name:Quidel Triage BNP CalibratorsProduct code:98202 1.2.Relevant identified uses of the substance or mixture and uses advised against1.2.1.Relevant identified usesIndustrial/Professional use spec: IndustrialFor professional use onlyNo1.2.2.Uses advised againstNo additional information available1.3.Details of the supplier of the safety data sheetQuidel Cardiovascular Inc.9975 Summers Ridge RoadSan Diego, California 92121 - United StatesT 1.800.874.1517 - F 1.858.453.4338qehs@quidel.com - quidel.com1.4.Emergency telephone numberEmergency number:1-800-874-1517SECTION 2: Hazards identification2.1.Classification of the substance or mixtureClassification according to Regulation (EC) No. 1272/2008 [CLP]Skin Irrit. 2H315Skin Sens. 1H317Eye Irrit. 2H319Adverse physicochemical, human health and environmental effectsNo additional information available2.2.Label elementsLabeling according to Regulation (EC) No. 1272/2008 [CLP]Hazard pictograms (CLP):Signal word (CLP):WarningHazard statements (CLP):H315 - Causes skin irritationH317 - May cause an allergic skin reactionH319 - Causes serious eye irritationPrecautionary statements (CLP):P264 - Wash hands thoroughly after handlingP272 - Contaminated work clothing should not be allowed out of the workplaceP302 P352 - IF ON SKIN: Wash skin thoroughly with mild soap and waterP305 P351 P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, ifpresent and easy to do. Continue rinsingP321 - Specific treatment: Seek medical attention if ill effect developsP332 P313 - If skin irritation occurs: Get medical advice/attentionP333 P313 - If skin irritation or rash occurs: Get medical advice/attentionP337 P313 - If eye irritation persists: Get medical advice/attentionP362 P364 - Take off contaminated clothing and wash it before reuseP501 - Dispose of contents/container: Dispose in a safe manner in accordance with local/national regulationsGHS072.3.Other hazardsNo additional information availableEN (English US)Printed on: 26 Mar 2019, 11:32:00 am;1/7

Official CopyApproved for UseSDS-98202T-ENRevision: 1Revision/Effective Date: 02 May 2018Quidel Triage BNP CalibratorsSafety Data Sheet SDS-98202T-ENaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations and Regulation (EC) No. 1907/2006 (REACH) with its amendmentRegulation (EU) 2015/830SECTION 3: Composition/Information on ingredients3.1.SubstanceNot applicable3.2.MixtureNameProduct identifier%ProClin 3000.1Sodium Azide(CAS No) 55965-84-9(EC index no) 613-167-00-5(CAS No) 26628-22-8(EC no) 247-852-1(EC index no) 011-004-00-7Classification according toDirective 67/548/EECR43 0.1Not ClassifiedNameProduct identifier%ProClin 300(CAS No) 55965-84-9(EC index no) 613-167-00-50.1Sodium Azide(CAS No) 26628-22-8(EC no) 247-852-1(EC index no) 011-004-00-7 0.1Classification according toRegulation (EC) No.1272/2008 [CLP]Acute Tox. 3 (Oral), H301Acute Tox. 3 (Dermal), H311Acute Tox. 3(Inhalation:dust,mist), H331Skin Corr. 1B, H314Skin Sens. 1, H317Aquatic Acute 1, H400Aquatic Chronic 1, H410Acute Tox. 2 (Oral), H300Aquatic Acute 1, H400Aquatic Chronic 1, H410NameProClin 300Product identifier(CAS No) 55965-84-9(EC index no) 613-167-00-5Specific concentration limits(C 0.0015) Skin Sens. 1, H317( 0.06 C 0.6) Eye Irrit. 2, H319( 0.06 C 0.6) Skin Irrit. 2, H315(C 0.6) Skin Corr. 1B, H314Full text of R- and H- phrases: see section 16SECTION 4: First aid measures4.1.Description of first aid measuresFirst-aid measures general:Under normal conditions of use, no adverse effects to health have been observed.First-aid measures after inhalation:Not expected to present a significant inhalation hazard under anticipated conditions of normaluse.First-aid measures after skin contact:Gently wash with plenty of soap and water.First-aid measures after eye contact:Not expected to present a significant eye contact hazard under anticipated conditions ofnormal use.First-aid measures after ingestion:Not expected to present a significant ingestion hazard under anticipated conditions of normaluse.4.2.Most important symptoms and effects, both acute and delayedSymptoms/injuries:Not expected to present a significant hazard under anticipated conditions of normal use.Symptoms/injuries after inhalation:None under normal use.Symptoms/injuries after skin contact:None under normal use.Symptoms/injuries after eye contact:None under normal use.Symptoms/injuries after ingestion:None under normal use.Symptoms/injuries upon intravenousadministration:None under normal use.Chronic symptoms:None under normal use.4.3.Indication of any immediate medical attention and special treatment neededTreat symptomatically.SECTION 5: Firefighting measures5.1.Extinguishing mediaSuitable extinguishing media: Water spray. Foam.Unsuitable extinguishing media: No unsuitable extinguishing media known.EN (English US)Printed on: 26 Mar 2019, 11:32:00 am;2/7

Official CopyApproved for UseSDS-98202T-ENRevision: 1Revision/Effective Date: 02 May 2018Quidel Triage BNP CalibratorsSafety Data Sheet SDS-98202T-ENaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations and Regulation (EC) No. 1907/2006 (REACH) with its amendmentRegulation (EU) 2015/8305.2.Special hazards arising from the substance or mixtureFire hazard: No direct or indirect fire hazard identified.Explosion hazard: No direct explosion hazard.Reactivity: The product is non-reactive under normal conditions of use, storage and transport.5.3.Advice for firefightersPrecautionary measures fire: Evacuate area. Stop leak if safe to do so.Firefighting instructions: No specific fire-fighting instructions required.Protection during firefighting: Do not enter fire area without proper protective equipment, including respiratory protection.SECTION 6: Accidental release measures6.1.Personal precautions, protective equipment and emergency proceduresGeneral measures6.1.1.: Absorb spillage to prevent material damage.For non-emergency personnelProtective equipment: Protective clothing as deemed necessary.Emergency procedures: Do not get in eyes, on skin, or on clothing. No open flames, no sparks, and no smoking.Evacuate unnecessary personnel. Keep containers closed.Measures in case of dust release: No effects known.6.1.2.For emergency respondersProtective equipment: Do not attempt to take action without suitable protective equipment.Emergency procedures: Stop leak if safe to do so.6.2.Environmental precautionsAvoid release to the environment.6.3.Methods and material for containment and cleaning upFor containment:Collect spillage and/or debris.Methods for cleaning up:Absorb spillage to prevent material damage.6.4.Reference to other sectionsFor further information refer to section 8: "Exposure controls/personal protection". For further information refer to section 13.SECTION 7: Handling and storage7.1.Precautions for safe handlingAdditional hazards when processed:None known.Precautions for safe handling:Do not get in eyes, on skin, or on clothing. Keep away from heat, hot surfaces, sparks, openflames and other ignition sources. No smoking. Keep container tightly closed. Keep out ofreach of children.Hygiene measures:Always wash hands after handling the product. Do not eat, drink or smoke when using thisproduct.7.2.Conditions for safe storage, including any incompatibilitiesTechnical measures:Comply with applicable regulations. Proper handling and disposal methods should beestablished by the laboratory in accordance with local, state, federal and national regulations.Storage conditions:Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. Nosmoking. Store as directed in product literature. Stable until the expiration date stated on thelabel when stored at -20 C or colder in a non-defrosting freezer away from the freezer door.Vial is stable at 2-10 C for 30 days after initial use or when removed from frozen storage.Incompatible products:None known.Incompatible materials:Keep away from heat sources.Heat-ignition:No direct or indirect fire or ignition sources identified.Prohibitions on mixed storage:None known.Storage area:Keep container as directed in product literature.Special rules on packaging:Proper handling and disposal methods should be established by the laboratory in accordancewith local, state, federal and national regulations.Packaging materials:No data available.7.3.Specific end use(s)None known.EN (English US)Printed on: 26 Mar 2019, 11:32:00 am;3/7

Official CopyApproved for UseSDS-98202T-ENRevision: 1Revision/Effective Date: 02 May 2018Quidel Triage BNP CalibratorsSafety Data Sheet SDS-98202T-ENaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations and Regulation (EC) No. 1907/2006 (REACH) with its amendmentRegulation (EU) 2015/830SECTION 8: Exposure controls/personal protection8.1.Control parametersNo additional information available8.2.Exposure controlsAppropriate engineering controls:Wear recommended personal protective equipment.Personal protective equipment:Avoid all unnecessary exposure. Gloves. In case of splash hazard: safety glasses. Protectiveclothing.Thermal hazard protection:Not applicable.Environmental exposure controls:Avoid release to the environment.Consumer exposure controls:Avoid contact during pregnancy/while nursing.Other information:Do not eat, drink or smoke when using this product.SECTION 9: Physical and chemical properties9.1.Information on basic physical and chemical propertiesPhysical state:LiquidColor:No data availableOdor:No data availableOdor threshold:No data availablepH:No data availableRelative evaporation rate (butyl acetate 1):No data availableMelting point:No data availableFreezing point:No data availableBoiling point:No data availableFlash point:No data availableAuto-ignition temperature:No data availableDecomposition temperature:No data availableFlammability (solid, gas):No data availableVapor pressure:No data availableRelative vapor density at 20 C:No data availableRelative density:No data availableSolubility:No data availableLog Pow:No data availableLog Kow:No data availableViscosity, kinematic:No data availableViscosity, dynamic:No data availableExplosive properties:No data availableOxidizing properties:No data availableExplosion limits:No data available9.2.Other informationNo additional information availableSECTION 10: Stability and reactivity10.1.ReactivityThe product is non-reactive under normal conditions of use, storage and transport.10.2.Chemical stabilityStable until the expiration date stated on the label when stored at -20 C or colder in a non-defrosting freezer away from the freezer door. Vial is stable at2-10 C for 30 days after initial use or when removed from frozen storage.EN (English US)Printed on: 26 Mar 2019, 11:32:00 am;4/7

Official CopyApproved for UseSDS-98202T-ENRevision: 1Revision/Effective Date: 02 May 2018Quidel Triage BNP CalibratorsSafety Data Sheet SDS-98202T-ENaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations and Regulation (EC) No. 1907/2006 (REACH) with its amendmentRegulation (EU) 2015/83010.3.Possibility of hazardous reactionsNo dangerous reactions known under normal conditions of use.10.4.Conditions to avoidNone under recommended storage and handling conditions (see section 7).10.5.Incompatible materialsNone known.10.6.Hazardous decomposition productsUnder normal conditions of storage and use, hazardous decomposition products should not be produced.SECTION 11: Toxicological information11.1.Information on toxicological effectsAcute toxicityProClin 300 (55965-84-9)LD50 oral ratATE CLP (oral)ATE CLP (dermal)ATE CLP (dust, mist)Sodium Azide (26628-22-8)ATE CLP (oral)Skin corrosion/irritation:Not classified53 mg/kg (Rat; Literature study)53.000 mg/kg body weight300.000 mg/kg body weight0.500 mg/l/4h5.000 mg/kg body weight:Not classifiedSerious eye damage/irritation:Not classifiedRespiratory or skin sensitization:Not classifiedGerm cell mutagenicity:Not classifiedCarcinogenicity:Not classifiedReproductive toxicity:Not classifiedSpecific target organ toxicity (single exposure):Not classifiedSpecific target organ toxicity (repeatedexposure):Not classifiedAspiration hazard:Not classifiedPotential adverse human health effects andsymptoms:No data availableOther information:Information on effects: refer to section 4.SECTION 12: Ecological information12.1.ToxicityProClin 300 (55965-84-9)LC50 fish 1EC50 Daphnia 1Threshold limit algae 10.28 mg/l (LC50; 96 h; Lepomis macrochirus)0.16 mg/l (EC50; 48 h; Daphnia magna)0.018 mg/l (EC50; 72 h; Pseudokirchneriella subcapitata)Sodium Azide (26628-22-8)LC50 fish 1LC50 other aquatic organisms 1EC50 Daphnia 1EC50 other aquatic organisms 10.8 mg/l (LC50; 96 h)1 (1 - 10) mg/l (96 h)4.2 mg/l (EC50; 48 h)5 (5 - 14) mg/l (Protozoa; TOXICITY TEST)12.2.Persistence and degradabilityProClin 300 (55965-84-9)Persistence and degradabilityBiochemical oxygen demand (BOD)Chemical oxygen demand (COD)ThODBOD (% of ThOD)No (test)data on mobility of the components available.Not applicableNot applicableNot applicableNot applicableEN (English US)Printed on: 26 Mar 2019, 11:32:00 am;5/7

Official CopyApproved for UseSDS-98202T-ENRevision: 1Revision/Effective Date: 02 May 2018Quidel Triage BNP CalibratorsSafety Data Sheet SDS-98202T-ENaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations and Regulation (EC) No. 1907/2006 (REACH) with its amendmentRegulation (EU) 2015/830Sodium Azide (26628-22-8)Persistence and degradabilityBiochemical oxygen demand (BOD)Chemical oxygen demand (COD)ThODBOD (% of ThOD)12.3.Biodegradability: not applicable.Not applicableNot applicableNot applicableNot applicableBioaccumulative potentialProClin 300 (55965-84-9)Bioaccumulative potentialNot established.Sodium Azide (26628-22-8)Bioaccumulative potentialNot bioaccumulable.12.4.Mobility in soilNo additional information available12.5.Results of PBT and vPvB assessmentNo additional information available12.6.Other adverse effectsNo additional information availableSECTION 13: Disposal considerations13.1.Waste treatment methodsRegional legislation (waste):Waste treatment methods:Disposal must be done according to official regulations.Dispose of contents/container in accordance with licensed collector’s sorting instructions.Sewage disposal recommendations:Disposal must be done according to official regulations.Waste disposal recommendations:Avoid release to the environment. Unused Quidel Triage BNP Calibrators should be disposedof in accordance with your facility’s solid waste disposal policies.Additional information:Clean up even minor leaks or spills if possible without unnecessary risk.Ecology - waste materials:Avoid release to the environment.SECTION 14: Transport informationIn accordance with ADR / RID / IMDG / IATA / ADN14.1.UN numberNot regulated for transport14.2.UN proper shipping nameNot applicable14.3.Transport hazard class(es)Not applicable14.4.Packing groupNot applicable14.5.Environmental hazardsOther information14.6.Special precautions for user14.6.1.Overland transport:No supplementary information available.In accordance with ADR / RID / IMDG / IATA / ADNNo additional information available14.6.2.Transport by seaIn accordance with ADR / RID / IMDG / IATA / ADNNo additional information available14.6.3.Air transportIn accordance with ADR / RID / IMDG / IATA / ADNNo additional information availableEN (English US)Printed on: 26 Mar 2019, 11:32:00 am;6/7

Official CopyApproved for UseSDS-98202T-ENRevision: 1Revision/Effective Date: 02 May 2018Quidel Triage BNP CalibratorsSafety Data Sheet SDS-98202T-ENaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations and Regulation (EC) No. 1907/2006 (REACH) with its amendmentRegulation (EU) 2015/83014.7.Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicableSECTION 15: Regulatory information15.1.Safety, health and environmental regulations/legislation specific for the substance or mixture15.1.1.EU-RegulationsContains no REACH substances with Annex XVII restrictionsContains no REACH candidate substancesContains no REACH Annex XIV substances.15.1.2.National regulationsNo additional information available15.2.Chemical safety assessmentNot listed under California Proposition 65SECTION 16: Other informationIndication of changes:Revision - See : *.Not applicableFull text of R-, H- and EUH-phrases:Acute Tox. 2 (Oral)Acute Tox. 3 (Dermal)Acute Tox. 3 (Inhalation:dust,mist)Acute Tox. 3 (Oral)Aquatic Acute 1Aquatic Chronic 1Skin Corr. 1BSkin Sens. 1H300H301H311H314H317H331H400H410R43Acute toxicity (oral) Category 2Acute toxicity (dermal) Category 3Acute toxicity (inhalation: dust, mist) Category 3Acute toxicity (oral) Category 3Hazardous to the aquatic environment - Acute Hazard Category 1Hazardous to the aquatic environment - Chronic Hazard Category 1Skin corrosion/irritation Category 1BSkin sensitization Category 1Fatal if swallowedToxic if swallowedToxic in contact with skinCauses severe skin burns and eye damageMay cause an allergic skin reactionToxic if inhaledVery toxic to aquatic lifeVery toxic to aquatic life with long lasting effectsMay cause sensitization by skin contactSDS EU (Reach Annex II) Quidel April 2018This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed asguaranteeing any specific property of the productEN (English US)Printed on: 26 Mar 2019, 11:32:00 am;7/7

SignatureManifestOfficial CopyApproved for UseSDS-98202T-ENRevision: 11 ofRevision/Effective Date: 02 PageMay 20181Signature ManifestDocument Number: SDS-98202T-ENTitle: Quidel Triage BNP CalibratorsRevision: 1All dates and times are in US/Pacific.ECO-5388 CR-7399 Quidel SDSCollaborationName/SignatureTitleDateMagdalena PatenaQuality Assurance Specialist I 24 Apr 2018, 10:00:40 AM(MAGDALENA.PATENA)Rachael Williamson (WILLIRA) Sr.Manager, Regulatory Affairs 25 Apr 2018, 08:31:12 AMJulia David (JULIA.DAVID)Document Control Analyst27 Apr 2018, 09:12:10 AMMeaning/ReasonComplete & QuitCompleteCompleteApprovalsName/SignatureMark Johnson(MARK.JOHNSON)Rachael Williamson (WILLIRA)Desiree Knight(DESIREE.KNIGHT)Michael Imrich(MICHAEL.IMRICH)Robert Schmidt (SCHMIRO)Julia David (JULIA.DAVID)TitleDateMeaning/ReasonSenior Manager, EH&S27 Apr 2018, 09:17:51 AMApprovedSr.Manager, Regulatory Affairs 27 Apr 2018, 09:30:51 AMApprovedEH&S Coordinator27 Apr 2018, 09:42:27 AMApprovedVP, Operations& Site Leader29 Apr 2018, 10:14:53 AMApprovedSenior Director, Quality AssurDocument Control Analyst30 Apr 2018, 10:23:10 AM1 May 2018, 08:10:47 g/ReasonJulia David (JULIA.DAVID)Document Control Analyst2 May 2018, 09:30:36 AMApprovedFinal ReleaseName/SignatureTitleDateMeaning/ReasonJulia David (JULIA.DAVID)Document Control Analyst2 May 2018, 09:31:57 AMApprovedPrinted on: 26 Mar 2019, 11:32:00 .819/%7BB9809F9F-7319-436. 5/2/2018

ProClin 300 (55965-84-9) LD50 oral rat 53 mg/kg (Rat; Literature study) ATE CLP (oral) 53.000 mg/kg body weight ATE CLP (dermal) 300.000 mg/kg body weight ATE CLP (dust, mist) 0.500 mg/l/4h Sodium Azide (26628-22-8) ATE CLP (oral) 5.000 mg/kg body weight Skin corrosion/irritation : Not classified Serious eye damage/irritation : Not classified

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Page 5 of 86 General Information Quidel Contact Information Contact Quidel Technical Support from 7:00 a.m. to 5:00 p.m. Pacific Time Tel: 800.874.1517 (in the U.S.); 858.552.1100 (outside the U.S.) Fax: 858.552.7905 Email: technicalsupport@quidel.com or contact your local distributor Website: quidel.com If outside the U.S. contact local distributor or one of the Technical Support centers .

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