Sofia Lyme FIA, Sofia 2 Lyme FIA, Sofia 2 Lyme+ FIA

Quidel Corporation

Revision date : 2018-11-28

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GHS07
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

55965-84-9

Name of the chemical

3(2H)-Isothiazolone, 5-chloro-2-methyl-, mixt. with 2-methyl-3(2H)-isothiazolone

Concentration

0.03

General Information

Revision date

2018-11-28

Product name

Sofia Lyme FIA, Sofia 2 Lyme FIA, Sofia 2 Lyme+ FIA

1.2.1 Relevant identified uses

This qualitative test is intended for use as an aid in the diagnosis of Lyme disease Components Individually pouched Test Cassettes, Blood Collection and Preparation Kit (contains Reagent Solution), Positive Control, and Negative Control

Emergency telephone

1.866.519.4752

Icons in SDS

GHS07

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)

H315, H317, H319

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

Kit Component Reagent Solution Sensitizer Skin Skin Sensitizer (Category 1) (0.03% Proclin 300) Eye Irritation (Category 2A) Positive Control and Negative Control Irritant, Sensitizer Eyes, skin Skin Irritation (Category 2) (0.3% Microcide III) Skin Sensitizer (Category 1)

2.2 Label elements

Component

Precautionary statements

H317 May cause an allergic P264 Wash hands thoroughly after handling. skin reaction. P303+P361+P353: IF ON SKIN (or hair): Remove immediately all Reagent Solution contaminated clothing. Rinse skin with water. (0.03% Proclin 300) P333+P313: Warning If skin irritation or rash occurs: Get medical attention. H315 Causes skin irritation. P264 Wash hands thoroughly after handling. H317 May cause an allergic P280 Wear protective gloves and eye protection. skin reaction. P305+P351+P338 Positive Control H319 Causes serious eye Negative Control If in eyes: Rinse cautiously with water for several irritation. minutes. Remove contact lenses, if present and (0.3% Microcide III) easy to do. Continue rinsing. Warning P302+P352 IF ON SKIN: Rinse skin with water. 1. Avoid release to the environment (P273).

Supplemental label elements

2. Follow Universal Precautions when working with this kit. Refer to additional information in Section 7, Handling and Storage.

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