GS HIV Combo Ag/Ab EIA

SECTION 2: Hazards identification

HAZARDOUS COMPONENTS This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Specific warnings are given in the instructions for use. The absence of a specific warning should not be interpreted as an indication of safety. The following information is furnished for those product hazardous constituents that require regulatory control or disclosure at the concentration found in the product. Refer to Section 16 for the full text of any solely abbreviated or coded hazard statements provided below and for the Key / legend to abbreviations and acronyms. GS HIV Combo Ag/Ab EIA [Catalog # 12003863] Component *

Contains

R1. Microwell Strip - Microwell plate coated with monoclonal antibodies to HIV p24 (mouse) and purified HIV-1 and HIV-2 Plate (50 plates) antigens. - Potential residue of ProClin 300 used as a production preservative (aspirated prior to drying strips). - Tabs are labeled “JJ” - Contains sealed pelletized desiccant packet: There are no health hazards associated with intact desiccant container; however, health hazards could result from dusts generated if the packet is cut, split or otherwise compromised and is crushed. C0. Negative Control - Normal human serum/plasma that is non-reactive for HBsAg, HIV-1 Ag and antibodies to HIV and HCV 10 vials (1.5 mL) (amber / yellow liquid). Catalog No. 26220 - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C1. HIV-1 Ab Positive - Heat-treated human serum/plasma containing HIV-1 antibody, non-reactive for HBsAg and antibody to HCV Control (yellow or green aqueous solution). 10 vials (1.5 mL) - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient active ingredient: 9.5-9.9% 2-methyl- Catalog No. 26221 4-isothiazolin-3-one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C2. HIV-2/O Ab - Murine monoclonal antibody to HIV-2 and Rabbit HIV-1 Group O antibody diluted in normal human Positive Control serum/plasma; non-reactive for HBsAg, and antibodies to HCV (yellow or green aqueous solution). 10 vials (1.5 mL) - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient active ingredient: 9.5-9.9% 2-methyl- Catalog No. 26222 4-isothiazolin-3-one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C3. HIV Ag Positive - Purified HIV-1 viral lysate antigen inactivated with heat and a chaotropic agent, in synthetic diluent (blue-green Control aqueous liquid). 10 vials (1.5 mL) - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965- Catalog No. 26223 0.1% Tartrazine [FD&C Yellow #5, Acid Yellow 23; C16H9N4O9S2•3Na]; CAS# 1934-21-0; EC 217-699-5. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory WARNING requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C4. Cutoff Calibrator - Normal human serum/plasma that is non-reactive for HBsAg, HIVAg and antibodies to HIV and HCV (amber / 20 vials (1.7 mL) yellow liquid). Catalog No. 26224 - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient active ingredient: 9.5-9.9% 2-methyl- 4-isothiazolin-3-one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. GS HIV Combo Ag/Ab EIA [Catalog # 12003863] Component * R6. Conjugate 1 - Biotinylated polyclonal antibodies to HIV-1 p24 (sheep) in a buffer with protein stabilizers and yellow-green 20 bottles (10 mL) dye Catalog No. 26225 - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-

Precautionary statements

(statements for p product intende d use and as cod dified on the pro oduct label) P280 Wear protective e gloves / protec ctive clothing / ey ye protection / f face protection. P302 + P352 IF ON SKIN: W Wash with plenty y of soap and wa ater. P333 + P313 If skin irritation n or rash occurs: Get medical adv vice/ attention. P501 Dispose of cont tents and contain ner in accordanc ce to local, region nal, national and d international re egulations. Suppleme ental Precautiona ary Statements (a (additional preca autions to consid der relative to sp pecific customer use): P261 Avoid breathing g mist / vapors/v vapours / spray. P272 Contaminated w work clothing sh hould not be allow wed out of the w workplace. [Source: Raw w Material vendo or SDS, CCOHS databases and r regulatory resea arch] SECTI ION 3: COM MPOSITION N/INFORMA ATION ON IN NGREDIEN NTS The e following in formation is f furnished for t those product hazardous con nstituents that t require regul latory control or disclosure rega ardless of the c concentration found f in the pr roduct. Note th hat the informa ation here is o often based on data from the chemical raw mat terial safety d data sheet and d literature (LD D50, exposure limits, etc.). Chemical con nstituents that t do not requi ire regulatory disc closure are not t generally incl luded here. Th is product con ntains a signific cantly diluted c concentration i in an aqueous solution, thus the assessment be elow has not considered c the dilution reduc ction effect on the hazard. T That hazard com mmunication i information is prov vided in Sectio on 2 above. So ome componen nts were tested d at the concen ntration found in the kit. In that case, the assessment is prov vided for the c chemical dilutio on tested and t the tested conc centration will b be provided at t the beginning g of the Chemic cal Ingredient Dat ta/Information box. Refer to o section 16 fo or the full text t of any Comp prehensive GH HS-based Clas ssification state ements coded belo ow, for the list of sources util lized in the ass sessment and fo or the Key / leg gend to abbrev viations and acr ronyms. P Page 4 of 19 GS H HIV Com bo Ag/Ab EIA [Cata alog # 12003863] Chemical Ingr redient Data / In nformation Ch hemical Ingred dient: Dimeth hyl-sulfoxide [D DMSO] Chemic cal concentratio ons found in th his product: ≤ 5 % in R8, an aqueous solut tion Da ata for Concentr rated / 100% ch hemical used in n the product m ixture (concentr ration tested): C CAS#: 67-68-5 (100%) LD50 ( (oral-rat): 14500 0 mg/kg (100%) E EC No: 200-644 4-3 (100%) LC50 ( (inhalation-rat): 1600 mg/m3 (4 h hr) (100%) R RTECS#: PV62 10000 (100%) LD50 ( (skin-rabbit): >5 000 mg/m3 (100 0%) I Index No: NA ( 100%) LC50 ( (96 hr-fish): NE mg/L (100%) C Chemical Formu ula: C2H6OS (10 00%) Flash p point: 188-192°F F / 86.7-88.9°C (100%) M Molecular weigh ht: 78.13 g/mol ( (100%) Fla ammable limits: L LEL/LFL is 3.5% %; UEL/UFL is 42% vv in air ( 100%) Synonyms/Trad e Names: Dimet thyl sulfoxide; Dimethyl sulph hoxide; Dimexid de; Dipirartril-tr ropico; DMS-70 0; DMS-90; DM MSO; Dolicur; Domoso; Dromisol; Dur rasorb; A 10846 6; Deltan; Dem meso; Demasorb b; Demavet; De emsodrox; Derm masorb; Gamaso ol 90; Hyadur; Infiltrina; M 176, Me ethane, sulfiny lbis-; Methylsu ulfinylmethane; Somipront; S SQ 9453, To psym; NSC-76 63; Rimso-50; Sulfinylbi is(methane); Syn ntexan Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (100%): N No Pictogram re equired W WARNING Fla. Liq. Cat. 4 H227 P210, P280, P370 P + P378, P4 03 + P235, P501 1 Ch hemical Ingredi ent: Citric acid d Chemica al concentrations s found in this pr roduct: <.1.5% w/v in R8 Da ata for Concentr rated / 100% ch hemical used in n the product m ixture (concentr ration tested): C CAS#: 77-92-9 (100%) LD50 ( (oral-rat): 5400 m mg/kg E EC No: 201-069 9-1 (100%) LC50 ( (inhalation-rat): N NE R RTECS#: GE73 50000 (100%) LD50 ( (skin-rabbit): >2 000 mg/kg I Index No: NA ( 100%) T Toxicity to fish mortality LC50 - Leuciscus idus melanotus - 440 0 mg/l - 48 h Me ethod: OECD Te est Guideline 203 3 C Chemical Formu ula: C6H8O7 (100 0%) pH val lue: 1.8 at ca.50 g/l at 25 °C (77 7 °F) M Molecular weigh ht: 192.12 g/mol l (100%) Synonyms/Trad e Names: Acilet tten; Anhydrou us citric acid d; Citretten; Citro; 2-Hydr roxy-1,2,3-propa anetricarboxylic c acid; beta- Hydroxytr ricarballylic acid d; Kyselina citro onova Skin corrosion/i rritation: Skin - rabbit - Mild ski in irritation - OE ECD Test Guide line 404 Serious eye dam mage/eye irritatio on: Eyes - rabbit - Irritating to ey yes. - OECD Tes st Guideline 405 5 R Respiratory or s kin sensitization n: Prolonged or r repeated exposur re may cause all lergic reactions i in certain sensiti ve individuals. Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (100%): W WARNING A Acute Tox. – skn n Cat. 5, Skin Ir rit. Cat. 1, Eye I Irrit. Cat. 2A H H313, H316, H3 319 P P264, P280, P30 05 + P351 + P33 38, P337 + P313 P Page 5 of 19 GS H HIV Com bo Ag/Ab EIA [Cata alog # 12003863] Chemical Ingr redient Data / In nformation Ch hemical Ingredi ent: Tartrazine e Solution Chemica al concentrations s found in this pr roduct: < 1% Da ata for Concentr rated / 100% ch hemical used in n the product m ixture (concentr ration tested): C CAS#: 1934-21- -0 (100%) LD D50 (oral-mouse) ): 12750 mg/kg (100%) E EC No: 217-699 9-5 (100%) LC C50 (inhalation-r rat): NE (100%) R RTECS#: UQ64 400000 (100%) LD D50 (skin-rabbit) ): NE (100%) C Chemical Formu ula: C16H9N4O9S S2•3Na LC C50 (96 hr-fish): NE (100%) M Molecular weigh ht: 534.36 g/mol l (100%) Synonyms/Trad e Names: Trisod dium 5-hydroxy- -1-(4-sulphophen nyl)-4-(4-sulpho ophenylazo)pyra azole-3-carboxyl late; Acid Yellow w 23; Yellow n no. 4; FD&C Ye ellow #5 Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (100%): D DANGER! R Resp. Sens. Cat. . 1, Skin Sens. Cat. C 1 H H317, H334 P P261, P272, P28 80, P285, P302 + P352, P304 + P P341, P321, P33 33 + P313, P342 2 + P311, P363, P P501 Ch hemical Ingred dient: ProClin n 300 Chemic cal concentratio ons found in th his product: 0.5 5% (0.015% ac ctive ingredie nt) in C3, R6 and R7b, 0.5% % in R7a prior to o Lyophilizatio on [Potential r residue dried on plates in R R1] Ha azardous ingredi ent concentratio n in raw materia al: 60-100% Glyco ols; 1-5% Mixture ( (3:1) of 5-Chlor ro-2-methyl-4-is sothiazolin-3-on ne (C4H5NOS; C CAS# 2682-20-4 4, EC# 220-239- -6) and 2-Meth hyl-2H -isothiaz zol-3-one (C4H4 ClNOS; CAS# 2 26172-55-4, EC# # 247-500-7) CAS#: 559 965-84-9 Index No: 6 613-167-00-5 Da ata for chemical l used in the pro oduct (concentra ation tested): R RTECS#: NE Synonyms/Trad e Names Synon nyms/Trade Na mes 5-Chloro-2 2-methyl-4-isoth hiazolin-3-one so olution; Kathon 300; Isothiazolin none chloride solution p pH value: 4.1 at 100 g/L (concen ntrated solution) ) F Flash Point: 244 4° F / 118° C (co oncentrated solut tion) L LD50 (oral-rat): 8 862 mg/kg (conc centrated solutio on) L LD50 (skin-rabbi it): 2,800 mg/kg (concentrated so olution) L LC50 (inhalation n-rat): NE L LD50 (skin-rabb it): NE Skin corrosion/i rritation - rabbit t – Corrosive (co oncentrated solut tion) Serious eye dam mage/eye irritatio on - rabbit - Corr rosive to eyes (co oncentrated solu ution) R Respiratory or s kin sensitization n - May cause all lergic skin reacti ion (concentrate ed solution) Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (100%): D DANGER! A Acute Tox. – ora al Cat. 4, Skin Corr. C Cat. 1B, Ey ye Damage.1, Sk kin. Sens. Cat.1, Aquatic Ac cute Cat. 1, Aqua atic Chronic Cat . 1 H H302, H314, H3 317, H410 P P261, P264, P27 70, P272, P273, P280, P301 + P3 312 + P330, P30 01 + P330 + P33 31, P303 + P36 61 + P353, P305 + P351 + P338 + P310, P333 + P313, P363, P3 391, P405, P501 P Page 6 of 19 GS H HIV Com bo Ag/Ab EIA [Cata alog # 12003863] Chemical Ingr redient Data / In nformation Ch hemical Ingred dient: Hydroc chloric acid Chemic cal concentratio ons found in th his product: ≤ 0 0.04N (< 0.4% % v/v HCl) Da ata for Concentr rated / 100% ch hemical used in n the product m ixture (concentr ration tested): C CAS#: 7647-01- -0 (concentrate s solution) LD D50 (oral, rat): 70 00 mg/kg (uncon nfirmed) E EC No: 231-595 5-7 (concentrate solution) LC C50 (inhalation-r rat): 3124 ppm/1 H I Index No: 017-0 002-01-X (conce entrate solution) LD D50 (skin-rabbit) ): Greater than 5 010 mg/kg (unc onfirmed) R RTECS#: MW4 4025000 (concen ntrate solution) Fi sh LC50 – Blueg gill/Sunfish – 28 2 mg/l – 48 h C Chemical Formu ula: HCl (concen ntrate solution) M Molecular weigh ht: 36.46 g/mol ( (concentrate solu ution) pH val lue: highly acidi ic (30-50% conc centrated solution n) S Synonyms/Trade e Names: Acide chlorhydrique; ; Acido clorid rico; Anhydrou us hydrochloric c acid; Chloorw waterstof; Chlo orohydric acid; Chlorowodor ; Chlorwassersto off; Hydrochlori de; Hydrogen ch hloride; Hydroge en chloride; Mur riatic acid; Spiri its of salt L LC50 (male rat): 1405 ppm (4-ho our exposure; he ead-only); cited a as 2810 ppm (1-h hour exposure; h head-only) (30-5 50% solution) LC50 (male ra at): 1562 ppm (4 -hour exposure; whole-body); ci ited as 3124 ppm m (1-hour exposu ure; whole-body y) (30-50% solut tion) S Skin corrosion/ir rritation: Skin - rabbit - Causes b burns. (30-50% solution) S Serious eye dam mage/eye irritatio on: Eyes - rabbit - Corrosive to e yes (30-50% sol lution) I IARC Group 3 Not classifiable e as to its carcino ogenicity to hum mans (30-50% so olution) Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (100%): D DANGER! Skin Corr. Cat. 1B, Eye Damage e Cat. 1, STOT SE Cat. 3, Met t. Corr. Cat. 1 H H290, H314, H3 335 P P234, P261, P26 64, P271, P280, P301 + P330 + P P331, P303 + P3 361 + P353, P30 04 + P340, P305 + P35 51 + P338, P310 , P321, P363, P3 390, P403 + P23 33, P405, P406, P P501 Ch hemical Ingred dient: 3,3’,5,5 ’-Tetramethy ylbenzidine, Di ihydrochlorid de Chemic cal concentratio ons found in th his product: < 0 0.3% w/v in R R9 Da ata for Concentr rated / 100% ch hemical used in n the product m ixture (concentr ration tested): C CAS#: 207738-0 08-7 (54827-17- -7 Free base) (10 00%) LD D50 (ipr-mouse): 135 mg/kg (100 0%) E EC No: 264-769 9-6 (100%) LD D50 (oral-rat): NE E R RTECS#: DV23 300000 (100%) LC C50 (inhalation-r rat): NE C Chemical Formu ula: C16H20N2•2H HCl (100%) LD D50 (skin-rabbit) ): NE M Molecular weigh ht: 313.27 g/mol l (100%) LC C50 (96 hr-fish): NE (100%) Synonyms/Trad e Names: TMB Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (100%): N Not a dangerous substance accor rding to GHS, U US HCS, EC CLP P and a analogous globa al GHS-based reg gulatory requirem ments. Ch hemical Ingred dient: ProClin n 950 Chemic cal concentratio ons found in th his product: ≤ 0 0.16% in C0, C C1, C2, and C C4 Da ata for chemical l used in the pro oduct (concentra ation tested): H Hazardous ingre edient concentrat tion in raw mate erial: the concent trated preservati ive contains: 5-10% of 2-m methyl-4-isothiaz zolin-3-one (activ ve ingredient). C CAS#: 2682-20- -4 (active ingred dient) LD50 (oral- -rat): No data av vailable (concent trated solution) E EC No: 220-239 9-6 (active ingred dient) LC50 (inhal lation-rat): No d data available (co oncentrated solu ution) R RTECS#: NE LD50 (skin- -rabbit): No data a available (conc centrated solutio on) C Chemical Formu ula: C4H5NOS (a active ingredient t) pH value: 3 3.0-6.0 (concent trated solution) Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (100%): D DANGER! A Acute Tox. -- in nhl., Cat. 3, Skin Corr., Cat. 1B, E Eye Damage, Ca at. 1, Skin Sens. , Cat. 1, Aquatic Ac cute, Cat. 1, Aqu uatic Chronic Cat t. 1 H H314, H317, H3 331, H410 P P261, P264, P27 71, P272, P273, P280, P301 + P3 330 + P331, P30 03 + P361 + P35 53, P305 + P35 51 + P338, P310 , P321, P403 + P233, P P405, P50 01 P Page 7 of 19 GS H HIV Com bo Ag/Ab EIA [Cata alog # 12003863] Chemical Ingr redient Data / In nformation Ch hemical Ingredi ent: Gentamici n sulfate Chemica al concentrations s found in this pr roduct: < 0.01% % from a 50 mg/ /ml Solution in C C0, C1, C2, C4 , R6 R7a, and R R7b Da ata for chemical l used in the pro oduct (concentra ation tested): C CAS#: 1405-41- -0 (100%) LD50 (o oral-rat): > 5000 0 mg/kg (100%, 5 50 mg/ml) E EC No: 215-778 8-9 (100%) LC50 (in nhalation-rat): N NE R RTECS#: LY26 625000 (100%) LD50 (s skin-rabbit): NE Synonyms/Trad e Names: Genta amicin sulfate sal lt; Garamycin; G Gentiomycin C Ra aw Material GHS HS / US HCS / EC C CLP Classific cation (10%): D DANGER! R Resp. Sens., Cat t. 1, Skin Sens., Cat. 1 H H317, H334 P P261, P272, P28 80, P285, P302 + P352, P304 + P P341, P321, P33 33 + P313, P342 + P311, P363, P P501 S Source: Raw Ma aterial vendor SD DS, CCOHS dat tabases and regu ulatory research h Bi iological Ingre edient Data / Information n The H HIV-1 Ab Positi ive Control (C1 1) was heat-treat ted to inactivate e the HIV. Hum man sera in reage ents were tested Hu uman Serum and fo ound non-reactiv ve for Hepatitis B surface antige en and antibodie es to HCV (the N Negative Contr rol (C0), HIV-1 [reactive and n non- Ag Po ositive Control (C3), and Cuto ff Calibrator (C C4) is are also n non-reactive for antibodies to H HIV). No known reactive in the test m method can offer r complete assur rance that HIV, , hepatitis B or C virus or othe er infectious age ents are absent. Negative Cont trol Moreo over, patient blo ood samples test ted with this kit t represent an un nknown, heighte ened hazard. Em mploy Standard (C0), HIV-1 A Ab and Universal U Precau utions when hand dling these reage ents and all hum man blood or spe cimens. Handle as if capable of Positive Contr rol transm mitting infectiou us disease, in a Biosafety Leve el 2 lab, applyin ng the guideline es from the cur rrent CDC/NIH (C1) and HIV- -2/O Biosaf fety in Microb iological and B Biomedical Lab boratories or W WHO Laborato ory Biosafety M Manual. Avoid Ab Positive Co ontrol splash hing, spills and t the generation o of aerosols. Secu ure in secondary y containment w with proper bioh hazard labeling. (C3), Cutoff Do no ot inhale mists o or aerosols; avoid d contact with s skin, eyes, muco ous membranes a and clothing. In case of contact with e eyes, immediate ly rinse with co opious water and d seek medical a attention. Emplo oy decontaminat tion procedures Calibrator (C4 4) with a appropriate deco on agent or disi infectant (typica ally a 1:10 dilu ution of househo old bleach, 70-8 80% ethanol or components] isopro opanol, an iodop phor like 0.5% W Wescodyne Plus (EPA Reg. #49 959-16), an o-ph henylphenol/amy yphenol such as 0.8% Vesphene (EPA A Reg. #1043-87 7), or equiv.) be efore discarding any materials u utilized or return ning equipment used to general use. . Dispose of th his material in accordance wit th local, region nal, national an nd international regula ations. Handle appropriately w with the requi isite Good Lab boratory Practic ces, Standard and Universal Preca autions. Persons handling blood s samples should h have the option of receiving hep patitis B vaccina ation. This m material is of an nimal origin (bov vine, rabbit, mur rine and sheep) and may be a po otential contact irritant. Hazard An nimal protein s Unkno own. Handle as s potentially inf fectious. The ch hemical, physica al and toxicolog gical properties have not been thorou ughly investigat ted. Handle ap ppropriately wit th the requisite e Good Labora atory Practices, Standard and Unive ersal Precaution ns. Dispose of t this material in n accordance w ith local, region nal, national an nd international regula ation. Inactiv vated Human Im mmunodeficienc cy Virus, type 1 (HIV-1), thoug gh verified to b be non-infectiou us. Handle as if In nactivated HIV V-1 capab le of transmittin ng infectious di sease, with Stan ndard and Univ versal Precautio ons in a Biosafe ety Level 2 lab, virus, [C3] applyi ing the guidelin nes from the curr rent CDC/NIH B Biosafety in Mi icrobiological an nd Biomedical L Laboratories or WHO O Laboratory Bi iosafety Manua l. Employ asep ptic technique f for personal pro otection and to avoid product contam mination; use of f a Biosafety Cab binet (BSC) may y be warranted o or desired in cert ain situations. A Avoid splashing, spills and the generati ion of aerosols. S Secure in second dary containmen nt with proper bi ohazard labeling g. Do not inhale mists or aerosols; avo oid contact with h skin, eyes, mu ucous membrane es and clothing . In case of con ntact with eyes, immed diately rinse w with copious wa ater and seek m medical attentio on. Employ dec contamination p rocedures with approp priate decon ag gent or disinfec ctant (typically a 1:10 dilutio on of household d bleach, 70-8 0% ethanol or isopro opanol, an iodop phor like 0.5% W Wescodyne Plus (EPA Reg. #49 959-16), an o-ph henylphenol/amy yphenol such as 0.8% Vesphene (EPA A Reg. #1043-87 7), or equiv.) be efore discarding any materials u utilized or return ning equipment used to general use. . Dispose of th his material in accordance wit th local, region nal, national an nd international regula ation. Handle appropriately w with the requis site Good Lab boratory Practic ces, Standard and Universal Preca autions. N NA: Not Applicable e. N NE: Not Established d or Unknown (un nable to locate data a); typically for co oncentrate form un nless otherwise spe ecified. P Page 8 of 19 GS HIV Combo Ag/Ab EIA [Catalog # 12003863] Related product information: ♦ Refer to Section 16 for the full text of any Comprehensive GHS-based Classification statements coded above. Refer to Section 16 for the list of sources utilized in the assessment and the Key / legend to abbreviations and acronyms. ♦ No significant adverse health effects are expected by any route for the miscellaneous hydrogen peroxide [H2O2, CAS# 7722- 84-1,-≤ 0.1% v/v in R8], salts, sugars, buffers, water, animal sera, and other chemicals found in the HRP conjugate, buffers with protein stabilizers, dyes, and sodium acetate solutions, in the kit volumes and/or concentrations present[chemical or dilution is not subject to GHS, US HCS, EC CLP or other GHS-based hazard labeling]. ♦ Component R1 contains < 0.1% of Cobalt (II) Chloride [CAS# 7646-79-9, EC No. 231-589-4], which is classified as an IARC Group 2B (possible human carcinogen) and EU Category 2 carcinogen, and silica quartz [CAS# 14808-60-7, EC No. 238-87-4], which in dust form is classified as an ACGIH Class A2 (suspected human carcinogen) and IARC Group 1 (carcinogenic to humans). These materials are pelletized and sealed in a desiccant packet within the plate pouch, which is unlikely to generate significant dust under normal conditions of use and is thus not typically considered a health hazard. However, health hazards could result from dusts generated if the packet is cut, split or otherwise compromised and a significant number of pellets were crushed to a powder form. Keep the desiccant packet intact as received in the microwell plate component package. ♦ According to the concept of Universal Precautions (29 CFR 1910.1030), all human blood and certain human body fluids must be treated as if known to be infectious for HIV, HBV and other bloodborne pathogens. No known test method can offer complete assurance that products derived from human blood will not transmit infection; thus, they should be handled as though they contain infectious agents. Furthermore, individual patient samples being tested represent a heightened, unknown hazard. Aerosolization/inhalation, contact and mucous membrane exposure should be avoided during sample and kit handling. Consider equipment that potentially comes in contact with human source material as contaminated until appropriately decontaminated. ♦ Do not eat, drink or smoke when using this product. ♦ Wear protective gloves / protective clothing / eye protection / face protection. Take off contaminated clothing and wash before reuse. SECTION 4: EMERGENCY FIRST AID MEASURES