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GenMark Diagnostics
ePLEX BCID PANEL

ePLEX BCID PANEL

Product catalog summary

Introduction
This document is a Safety Data Sheet (SDS) for ePlex® products, specifically detailing safety information for components within the ePlex cartridge, issued on April 11, 2017. It covers the Blood Culture Identification Panels and Fungal Pathogen Panels.

Section 1: Identification
The ePlex cartridge is used for blood culture identification and fungal pathogen panels. Main chemicals include Guanidine hydrochloride and Sodium perchlorate. The supplier is GenMark Diagnostics, with contact details for the US and Europe.

Section 2: Hazards Identification
The product is classified under various hazard categories, including acute oral toxicity, skin and eye irritation, and as an oxidizing solid. Key hazards include risks of ingestion, skin and eye irritation, and potential fire or explosion.

Section 3: Composition/Information on Ingredients
Lists chemical components, CAS numbers, and concentration ranges. Main chemicals are Guanidine hydrochloride and Sodium perchlorate, with specific hazard classifications.

Section 4: First Aid Measures
Instructions for eye contact, skin contact, ingestion, and inhalation. Emphasizes personal protective equipment and seeking medical attention if symptoms persist.

Section 5: Fire-Fighting Measures
Suitable extinguishing media include water spray, alcohol-resistant foam, carbon dioxide, and dry chemical. Special hazards include toxic fumes emission under fire conditions.

Section 6: Accidental Release Measures
Precautions include eliminating ignition sources and using personal protective equipment. Details methods for containment and cleaning up spills.

Section 7: Handling and Storage
Guidelines emphasize avoiding contact with skin and eyes and keeping the product away from ignition sources.

Section 8: Exposure Controls/Personal Protection
Outlines necessary personal protective equipment, including safety glasses, gloves, and respirators. Advises ensuring adequate ventilation.

Section 9: Physical and Chemical Properties
The product is a solid with a grayish-white appearance and a pungent odor. Various properties are listed, though many data points are unavailable.

Section 10: Stability and Reactivity
The product is stable under normal conditions but should be kept away from open flames and incompatible materials like strong acids and powdered metals.

Section 11: Toxicological Information
Provides information on potential health effects, including irritation and toxicity levels for main chemical components.

Section 12: Ecological Information
The product is not known to be hazardous to the environment, with specific ecotoxicity data for Guanidine hydrochloride. No information on bioaccumulation or endocrine disruption.

Section 13: Disposal Considerations
Waste should be disposed of according to local regulations. Contaminated packaging should be taken to an approved waste handling site.

Section 14: Transport Information
The product is not subject to dangerous goods regulations when sold in small quantities. Contains sodium perchlorate, classified under UN1502, with a hazard class of 5.1.

Section 15: Regulatory Information
The product complies with various international inventories. No chemical safety assessment is available.

Section 16: Other Information
H-Statements include H302, H315, H319, and H271. The SDS complies with EU regulations.

Conclusion
This SDS provides essential information for the safe handling, use, and disposal of the ePlex Blood Culture Identification Panels. Users are advised to follow guidelines and precautions to ensure safety and compliance with regulations.

Catalog excerpts

Introduction to Safety Data Sheets for ePlex® products The ePlex cartridge contains six separate components for which a safety data sheet is required. The figure below shows the location and name of each component in the cartridge. When reading the Safety Data Sheet, please note the component name shown under Product Name in Section 1.

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SAFETY DATA SHEET Issuing date 11-Apr-2017 Revision Date 11-Apr-2017 Revision Number 0 1.1. Product identifier Product name Detection/Salting Component for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel Synonyms ePlex Blood Culture Identification Gram-Negative Panel, EA002012, EA002112, Contains Guanidine hydrochloride; Sodium perchlorate 1.2. Relevant identified uses of the substance or mixture and uses advised against Recommended use In vitro diagnostic use, investigational use and for research use...

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WPS-GNMR-002CLPB - Detection/Salting Component for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel

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WPS-GNMR-002CLPB - Detection/Salting Component Revision Date 11-Apr-2017 for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel _____________________________________________________________________________________________ Sodium perchlorate For the full text of the H-Statements mentioned in this Section, see Section 16 Section 4. First aid measures 4.1. Description of first aid measures General advice Do not get in eyes, on skin, or on clothing. Show this safety data sheet to the doctor in attendance. Immediately...

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WPS-GNMR-002CLPB - Detection/Salting Component Revision Date 11-Apr-2017 for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel _____________________________________________________________________________________________ 5.3. Advice for firefighters Special protective equipment for fire-fighters As in any fire, wear self-contained breathing apparatus and full protective gear. Section 6. Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures ELIMINATE all ignition...

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WPS-GNMR-002CLPB - Detection/Salting Component for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel Revision Date 11 -Apr-2017 Biological occupational exposure limits This product, as supplied, does not contain any hazardous materials with biological limits established by the region specific regulatory bodies Derived No Effect Level No information available. Predicted No Effect Concentration No information available. (PNEC) Engineering measures Personal protective equipment Eye Protection Skin and body...

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WPS-GNMR-002CLPB - Detection/Salting Component Revision Date 11-Apr-2017 for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel Explosive properties No information available 10.1. Reactivity No data available. 10.2. Chemical stability Stable under normal conditions. 10.4. Conditions to avoid Keep away from open flames, hot surfaces and sources of ignition. Incompatible materials Organic materials. Strong acids. Powdered magnesium Powdered metals. Forms shock-sensitive mixtures with other materials including...

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WPS-GNMR-002CLPB - Detection/Salting Component Revision Date 11-Apr-2017 for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel Aspiration hazard Ecotoxicity effects Contains no substances known to be hazardous to the environment or not degradable in waste water treatment plants. 12.4. Mobility in soil No information available. This product does not contain any known or suspected endocrine disruptors Waste from residues / unused Dispose of in accordance with local regulations. products Contaminated packageing...

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WPS-GNMR-002CLPB - Detection/Salting Component for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel

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WPS-GNMR-002CLPB - Detection/Salting Component Revision Date 11-Apr-2017 for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel _____________________________________________________________________________________________ 5.1 14.3. Hazard class 14.4. Packing group Description 14.5. Environmental hazard. 14.6. Special Provisions ERG Code II UN1502, Sodium perchlorate, 5.1, II None None 5L Section 15. Regulatory information 15.1. Safety, health and environmental regulations/legislation specific for the substance...

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WPS-GNMR-002CLPB - Detection/Salting Component Revision Date 11-Apr-2017 for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel _____________________________________________________________________________________________ Disclaimer The information provided herein is correct to the best of our knowledge, information and belief at the date of its publication. The information provided is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not...

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SAFETY DATA SHEET Issuing date 11-Apr-2017 Revision Date 11-Apr-2017 Revision Number 0 1.1. Product identifier Product name Binding Component for: ePlex® Blood Culture Identification Gram-Negative Panel, ePlex Blood Culture Identification Gram-Positive Panel, ePlex Fungal Pathogen Panel Synonyms ePlex Blood Culture Identification Gram-Negative Panel, EA002012, EA002112, 1.2. Relevant identified uses of the substance or mixture and uses advised against Recommended use In vitro diagnostic use, investigational use and for research use Uses advised against No information available 1.3. Details of...

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