OraQuick HCV Kit Controls

OraSure Technologies, Inc

Revision date : 2011-03-11

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

2682-20-4

Name of the chemical

2-Methyl-2H-isothiazol-3-one

Concentration

N/A

General Information

Revision date

2011-03-11

Product name

OraQuick HCV Kit Controls

Product Synonyms

OraQuick® HCV Kit Controls

CAS No.

2682-20-4

1.2.1 Relevant identified uses

OraQuick® HCV Kit Controls are quality control reagents for use only with the OraQuick® HCV Rapid Antibody Test. The kit control components are human plasma-based reagents. The kit controls are specifically formulated and manufactured to ensure proper performance of the test. The HCV Positive Control will produce a reactive reddish-purple line at the Test (T) Zone. The HCV Negative Control will generate a non-reactive test result (no reddish-purple line at the Test (T) Zone)

Manufacturer Name

OraSure Technologies, Inc

Icons in SDS

Company Information

company name

OraSure Technologies, Inc

Section 2

SECTION 2: Hazards identification

The OraQuick® HCV Kit Controls individual components should be used 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. NOTE: Handling, storing or shipping of the complete packaged kit should pose no threat to the individual. If no leak or excessive damage is noted there is no recommended Personal Protective Equipment (PPE) required. If the products’ integrity is in question due to excessive damage or unforeseen circumstances, utilize proper safety procedures and handle using universal precautions including PPE (safety glasses/face protection and gloves) as per 29 CFR 1910.1030. Components

Contains

1 vial of 0.75ml HCV Positive 0.2ml of photochemcially inactivated human plasma positive for antibodies to HCV, diluted in a Control (Purple Cap) defibrinated pool of normal human plasma. Preservative: 2-methyl-4-isothiazolin-3-one. 1 vial of 0.75ml HCIV Negative 0.2ml of defibrinated pool of normal human plasma negative for antibodies to HCV. Preservative: Control (White Cap) 2-methyl-4-isothiazolin-3-one. COMMENTS: The Positive Control (purple capped vial) contains 0.2ml of photochemically inactivated human plasma positive for antibodies to HCV, diluted in a defibrinated pool of normal human plasma. The Negative Control (white capped vial) contains 0.2ml of defibrinated pool of normal human plasma. All control vials contain the chemical 2-methyl-4-isothiazolin-3-one as a preservative. All control vials are negative for Hepatitis B surface antigen and HIV-1/2 antibody. The vials contain no known active viruses; the test indication is based on the response to the antibody only.

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