Material Safety Data Sheet. Kit/Component Description. Dengue Dx NS1 Antigen Rapid Test

Transcription

1 TITLE: AUTHOR: Celina Evenson Page 1 of PRODUCT & COMPANY IDENTIFICATION Catalog No. RT1510 Kit/Component Description Rapid Test Manufacturer: Standard Diagnostics, Inc., , Hagal-dong, Giheung-gu, Yongin-si, Kyonggi-do, Korea, Distributer: Focus Diagnostics, Inc., Valley View Street, Cypress, CA 90630, U.S.A. Emergency Phone: (714) [U.S.A.] Monday Friday, 8:00 a.m. 5:00 p.m. 2.0 COMPOSITION, INFORMATION ON INGREDIENTS Catalog No.(s) Component(s) Ingredient(s) Conc. N/A Test strip membrane Gold conjugates : Mouse 0.27 ±0.05 μg monoclonal antidengue NS1 gold colloid CAS No.(s) N/A Test line: Mouse monoclonal anti-dengue NS1 Control line: Goat antimouse IgG 0.72 ±0.14 μg 0.72 ±0.14 μg N/A N/A

2 Page 2 of HAZARDS IDENTIFICATION The contents contained in this package may irritate the eyes, skin, and respiratory tract. May be harmful if swallowed. May be toxic if ingested. Splashes from solutions may produce severe eye and skin irritation. May cause irreversible eye damage. May cause burns upon contact (corrosive). May cause effects on the kidneys, central nervous system, and/or cardiovascular system. Effects may be delayed. Medical observation recommended upon exposure. 0.1% Sodium azide: Irritant to eyes, skin; blisters; headache; dizziness; blurred vision; low blood pressure. Highly toxic. Carcinogenicity: NTP- NO, IARC Monographs- None, OSHA Regulated- NO Medical Conditions: Generally Aggravated by Exposure: Eye / Skin hypersensitivity 4.0 FIRST AID MEASURES Skin Contact: Remove from source of exposure. Wash affected area with soap and water. Remove contaminated clothing and shoes. If irritation or signs of toxicity occur, seek medical attention. Eye Contact: Remove from source of exposure. Wash with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating eyelids with fingers. If irritation or signs of toxicity occur, seek medical attention. Ingestion: If irritation or signs of toxicity occur, seek medical attention. The following symptoms may occur: Irreversible eye damage. Medical conditions aggravated by exposure: Pre-existing eye ailments. Hypersensitivity. This material should be considered as being potentially infectious. 5.0 FIRE AND EXPLOSION DATA Flash Point: Not applicable Auto Ignition Temperature (ºF): Not applicable Flammable Limits: Not applicable LEL: Not applicable

3 Page 3 of 6 UEL: Not applicable Extinguishing Media: Suitable extinguishing agents including CO 2, Water Spray or Regular foam. Unusual Fire and Explosive Hazards: Not applicable Special Fire-Fighting Procedures: None 6.0 ACCIDENTAL RELEASE MEASURES Wear appropriate personal protective equipment, including but not limited to, protective eyewear, clothing, and gloves. Absorb into toweling or other absorbent material. Place in red bio-hazardous material bag and dispose of in accordance with approved institutional procedures for bio-hazardous material. 7.0 HANDLING & STORAGE Handling: Regard as potentially infectious. Do not eat, drink, smoke or apply cosmetics in laboratory areas. Do not mouth pipette reagents or samples by mouth. Avoid splashing and forming aerosols. Use reagents according to the product insert. Avoid extreme temperatures during transport. Eye Protection: Wear safety glasses or full face shield. Skin Protection: Wear protective clothing and gloves. Respiratory Protection: None required. Ventilation: None required. In-vitro diagnostics use only Storage: 1-30ºC

4 Page 4 of EXPOSURE CONTROLS, PERSONNEL PROTECTION Wear appropriate personal protective equipment when working with components or samples, including laboratory coats, disposable gloves and eye protection. Avoid hand and mouth contact. Wash hands as soon as possible after handling components or samples. 9.0 PHYSICAL & CHEMICAL PROPERTIES Boiling Point ( F): Aqueous mixtures- 100 C Vapor Pressure (mm Hg): Not applicable Vapor Density (Air = 1.0): Not applicable Solubility in Water: Aqueous mixtures- soluble Appearance: Packaged kit with aluminum pouch-sealed test cassettes and disposable droppers. Specific Gravity (Water = 1.0): Not applicable Percent Volatile by Volume (%): Not applicable Evaporation Rate: Not applicable ph: Not applicable Odor: Ordorless 10.0 STABILITY & REACTIVITY Stability: Stable Incompatibility: None identified when used appropriately Hazardous Polymerization: will not occur Storage conditions: 1-30ºC Materials to avoid: None known

5 Page 5 of TOXICOLOGICAL INFORMATION Not available ECOLOGICAL INFORMATION Not available DISPOSAL CONSIDERATIONS Dispose of according to local and national laws TRANSPORT INFORMATION Proper Shipping Name: Not applicable. Hazard Class and Number: Not applicable REGULATIONS: EUROPEAN INFORMATION Risk phrase R36-Irritating to eyes. R38-Irritating to skin. Safety Phrase S24- Avoid contact with skin. S25- Avoid contact with eyes. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S28- After contact with skin, wash immediately with plenty of soap

6 Page 6 of 6 S47- Keep at temperature not exceeding 1 30 C S56- Dispose of this material and its container at hazardous or special waste collection point SPECIAL PRECAUTIONS Hygienic Practices In Handling And Storage: This product should be handled using the same precautions employed when handling any potentially infectious material. Precautions For Repair and Maintenance of contaminated equipment: Follow good laboratory practices for decontamination such as the use of a 10% bleach solution or autoclave OTHER INFORMATION The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. Focus Diagnostics shall not be held liable for any damage resulting from handling or from contact with the kits or components. END OF DOCUMENT