General Information
Revision date
2014-11-05
Product name
Sofia Strep A+ FIA
1.2.1 Relevant identified uses
The Sofia Strep A+ FIA employs immunofluorescence technology to detect Group A Streptococcal
Emergency telephone
1.866.519.4752
Icons in SDS
Company Information
company name
Quidel Corporation
e-mail address of the competent person responsible for the Safety Data Sheet
qehs@quidel.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302, H319, H401
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
67/548/EEC The hazards associated with this product are related to the Reagent Solution that contains a 0.4N Hydrochloric Acid (1.2%) glass ampoule inside of a plastic bottle containing a 4M Sodium Nitrite (27.6%) solution. The Reagent Solution contains approximately 0.475 mL of Sodium Nitrite and 0.475 mL of Hydrochloric Acid and is considered as single use only. Emergency Overview Significant health effects are not anticipated from routine use of this kit when following the precautions listed within this SDS and the kit specific Package Insert. The Reagent Solution (Part #: 1263700) within this kit is considered hazardous as
Precautionary statements
Signal Component Word P305+P351+P338 H302 Harmful if swallowed. If in eyes: Rinse cautiously Reagent Solution Warning with water for several H319 Causes serious eye irritation. minutes. Remove contact H401 Toxic to aquatic life. lenses, if present and easy to do. Continue rinsing. Follow Universal Precautions when working with this kit.
Supplemental label elements
Avoid release to the environment.
2.1 Classification of the substance or mixture
Blood, cardiovascular system, Oxidizing liquids (Category 3) Effect, Toxic by Ingestion, smooth muscle Acute Toxicity, Oral (Category 4) Irritant Eye Irritation (Category 2A) Acute Aquatic Toxicity (Category 2) GHS Label Elements & Precautionary Statements Signal Component