ImmunoDOT Salmonella typhi

SECTION 2: Hazards identification

(2) HMIS Hazard Rating: 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. Component

Contains

R1 Assay Strips Nitrocellulose membrane on flexible polyvinyl chloride film backing [CAS# 9002- 86-2] consisting of the following antigens spotted onto the nitrocellulose 1 Assembly (25 strips) membrane: Human IgG (human serum), negative control and Salmonella typhi antigens (“O,” “H,” and Vi). Assay Strips are blocked and preserved with non-fat dry milk [Casein from bovine milk EINECS/ELINCS No 232-555-1, CAS# 9000-71-9] Flammable Solid R2 Diluent 0.01M Phosphate buffer solution with sodium chloride [CAS# 7647-14-5, EINECS/ELINCS No. 231-598-3] and bovine serum albumin [CAS# 9048-46-8, 1 bottle (50 mL) EINECS/ELINCS No. 232-936-2] (pH 6.2-7.6). Preserved with < 0.1% sodium azide [NaN3], EINECS/ELINCS No: 247-852-1 and CAS# 26628-22-8, dilution below EU regulated labeling levels (1999/45/EC– dilution < 0.1%). R3 Enhancer Saline solution with sodium chloride [CAS# 7647-14-5, EINECS/ELINCS No. 231- 1 bottle (50 mL) 598-3]. Preserved with < 0.1% sodium azide [NaN3], EINECS/ELINCS No: 247-852-1 and CAS# 26628-22-8, dilution below EU regulated labeling levels (1999/45/EC– dilution < 0.1%). Page 1 of 12 Effective Date 31 October 2025 R4 Conjugate Alkaline Phosphatase labeled goat anti-Human IgG and IgM in Tris buffer solution (Tris Base [EINECS/ELINCS No. 201-064-4, CAS# 77-86-1] and Tris-HCl 1 bottle (50 mL) [EINECS/ELINCS No. 214-684-5, CAS# 1185-53-1]) with 0.012% magnesium sulfate [EINECS/ELINCS No. 231-298-2, CAS# 7487-88-9], 0.0014% Zinc Chloride [EINECS/ELINCS No. 231-592-0, CAS# 7646-85-7, dilution below concentration limit per directive 98/8/EC], and bovine serum albumin [CAS# 9048-46-8, EINECS/ELINCS No. 232-936-2]. Preserved with < 0.1% sodium azide [NaN3], EINECS/ELINCS No: 247-852-1 and CAS# 26628-22-8, dilution below EU regulated labeling levels (1999/45/EC– dilution < 0.1%). R5 Developer 0.02% 5-bromo-4-chloro-3-indolyl phosphate [EC No. 229-506-1, CAS# 1 bottle (50 mL) 6578-06-9] and <0.05% p-nitro blue tetrazolium chloride [ EC No. 206-067-4, CAS# 298-83-9] in Tris buffer solution (Tris Base [EINECS/ELINCS No. 201-064-4, CAS# 77-86-1] and Tris-HCl [EINECS/ELINCS No. 214-684-5, CAS# 1185-53-1]) with <1% sodium chloride [CAS# 7647-14-5, EINECS/ELINCS No. 231-598-3], <1% magnesium sulfate [EC No. 231-298-2, CAS# 7487-88-9], and <1% N,N- Dimethylformamide [EC No. 200-679-5, CAS# 68-12-2, WARNING! H360D + H332

HMIS CODES

H=1, F=0, R=1 ++ RCRA Code: P105 (undiluted, 100%) + Page 2 of 12 H=2, F=2, R=0 ++ EINECS/ELINCS No: 200-679-5 (100%) +

EU Classification

None (due to dilution, < 0.1%); S 35-36 ++ Sodium azide is a biocidal preservative, which may be detrimental if enough is ingested (quantities above those found in the kit). Avoid contact with metals; sodium azide may react with lead or copper plumbing to form highly explosive metal azides. Buildup in metal plumbing has led to laboratory explosions, so flush with copious water when pouring dilute solutions down the drain to prevent such explosive buildup. This material and its container must be disposed of in a safe way and in accordance with local, regional and national regulations. The potential for adverse health effects is unknown for the highly diluted, small volume of sodium azide in this kit, but unlikely if handled appropriately, with the requisite Good Laboratory Practices and Universal Precautions. N,N-Dimethylformamide CAS# 68-12-2 (100%) + RTECS# LQ2100000 (100%) + LD50 (oral rat): 2800 mg/kg (100%) + LC50 (inhalation rat): 4h – 9 – 15 mg/L [0.775% in R5] LD50 Dermal – rabbit – 1500 mg/kg (100%) + PEL/TLV: 10 ppm (ceiling) (100%) + Flash point: 67⁰C (153⁰F) (100%) + RCRA Code: None ++ IATA/DOT ID: UN2265(undiluted,100%) + Repr. Cat 2; R61 – Xn; R20/21 – Xi; R36 – S53+S45 ++ TOXIC! N,N-Dimethylformamide may cause harm to the unborn child. It is harmful by inhalation and in contact with skin and irritating to eyes. Avoid contact with skin and eyes and avoid inhalation of vapor or mist. Keep away from all sources of ignition. Dispose of this material in accordance with local, regional and national regulations. The potential for adverse health effects is unknown for the highly diluted, small volume of N,N- Dimethylformamide in this kit. In case of accident or if you feel unwell, seek medical advice immediately. Handle appropriately with the requisite Good Laboratory Practices. Animal Proteins This material is of animal origin (bovine) and may be a potential contact irritant. Hazard Unknown. Handle as potentially infectious. The chemical, physical and toxicological [Components in R2, and properties have not been thoroughly investigated. R4] Handle appropriately with the requisite Good Laboratory Practices and Universal

Precautionary statements

Dispose of this material in accordance with local, regional and national regulations. Human Serum The Human sera in the components of this product were tested by an FDA approved method and found non-reactive for Hepatitis B surface antigen (HBsAg), and antibody [Components in R1] to Hepatitis C virus (HCV) and Human immunodeficiency virus type 1 and 2 (HIV-1/HIV- 2). No known test method can offer complete assurance that HIV, Hepatitis B or C virus or other infectious agents are absent. Moreover, patient blood samples tested with this kit represent an unknown, heightened hazard. Employ Universal Precautions when handling these reagents and all human blood, specimens or patient samples, which represent an unknown, heightened hazard. Handle as if capable of transmitting infectious disease, in a Biosafety Level 2 lab, applying the guidelines from the current CDC/NIH Biosafety in Microbiological and Biomedical Laboratories. Avoid splashing, Page 3 of 12 spills and the generation of aerosols. Secure in secondary containment with proper biohazard labeling. Do not inhale mists or aerosols; avoid contact with skin, eyes, mucous membranes and clothing during kit use and sample handling. In case of contact with eyes, immediately rinse with copious water and seek medical attention. Employ decontamination procedures, with appropriate decon agent/disinfectant (typically a 1:10 dilution of household bleach, 70-80% ethanol or isopropanol, an iodophor like 0.5% Wescodyne Plus [EPA Reg. #4959-16], an o-phenylphenol/amyphenol such as 0.8% Vesphene [EPA Reg. #1043-87], or equiv.) before discarding any materials utilized or returning equipment used to general use. Dispose of this material in accordance with local, regional and national regulations. Handle appropriately with the requisite Good Laboratory Practices and Universal Precautions. Persons handling blood samples should have the option of receiving hepatitis B vaccination. + The Kit Concentration was not tested; the values refer to the solution concentration as tested, designated by percentage within parentheses. ++ The Kit Concentration was tested or the values given were estimated for the general diagnostic laboratory usage of the kit reagent dilution. NE: Not Established or Unknown (unable to locate data); typically for concentrated form unless otherwise specified. Abbreviations for component HMIS hazard ratings are as follows: H=Health, F=Flammability, R=Reactivity General Kit Composite Health Hazards: ▪ No significant adverse health effects are expected by any route for the following chemical constituents in the kit volumes and concentrations present (dilution not subject to EU Directive labeling: • Diluted (<5%) Disodium orthophosphate heptahydrate [HNa2O4P·7H2O], CAS# 7782-85-6, EINECS/ELINCS No. unlisted. (R2) • Diluted (<1%) Sodium dihydrogen phosphate monohydrate [NaH2PO4·H2O], EINECS/ELINCS No. 231-449-2, CAS# 10049-21-5. (R2) • Diluted (<1%) Sodium Chloride [HCl], CAS# 7647-14-5, EINECS/ELINCS No. 231-598-3. (R2, R3, R5) • Diluted (<2%) 2-Amino-2-(hydroxymethyl)-1,3 propanediol (Tris base) [C4H11NO3], CAS# 77-86-1, EC No. 201- 064-4. (R4 and R5) • Diluted (<1%) Tris (hydroxymethyl) aminomethane hydrochloride (Tris-HCl) [C4H11NO3·HCl], CAS# 1185-53-1, EC No. 214-684-5. (R4 and R5) • Diluted (<1%) Magnesium sulfate [MgSO4], CAS# 7487-88-9, EC No. 231-298-2. (R4 and R5) • Diluted (<0.01%) Zinc Chloride [ZnCl2], CAS# 7646-85-7, EC No. 231-592-0. (R4) • Diluted (<0.02%) 5-bromo-4-chloro-3-indolyl phosphate p-toluidine salt [C8H6BrClNO4P·C7H9N], CAS# 6578- 06-9, EC No. 229-506-1. (R5) • Diluted (<0.05%) p-nitro blue tetrazolium chloride [C40H30Cl2N10O6], CAS# 298-83-9, EC No. 206-067-4. (R5) • No significant adverse health effects are expected by any route for the miscellaneous salts, buffers, protein- stabilizers, antibodies, conjugates, water or other non-reactive ingredients, in the kit volumes and/or concentrations present. ▪ 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. Page 4 of 12