Safety Documentation

Immudex’s products and components are classified as non-hazardous and therefore a Safety Data Sheet (SDS) is not required – please read our Non-hazard Classification Statement

However, we strongly recommend using prudent laboratory practices: avoiding unnecessary contact, and use of personal protective equipment, which may include chemical resistant gloves, eye protection, and lab coats, during the use of laboratory reagents

easYmer® Safety Documentation

Explanation of Symbols Used on Immudex Product Labeling

Symbol	Title of symbol	Explanatory Text	Reference
	CE marking of European Conformity	Indicates that the product is in conformity with applicable European regulations	IVDD 98/79/EC Annex X
	Manufacturer	Indicates the product manufacturer	ISO 15223-1:2016 Reference no. 5.1.1
	Batch code	Indicates the manufacturer’s batch code so that the batch or lot can be identified	ISO 15223-1:2016 Reference no. 5.1.5
	Catalog number	Indicates the manufacturer’s cataloge number so that the product can be identified	ISO 15223-1:2016 Reference no. 5.1.6
	Use-by date	Indicates the date after which the product is not to be used	ISO 15223-1:2016 Reference no. 5.1.4
	In vitro diagnostic medical device	Indicates a product that is intended to be used as an in vitro diagnostic medical device	ISO 15223-1:2016 Reference no. 5.5.1
	Contains sufficient for <n> tests	Indicates the total number of tests that can be performed with the device	ISO 15223-1:2016 Reference no. 5.5.5
	Serial number	Indicates the manufacturer’s serial number so that a specific product can be identified	ISO 15223-1:2016 Reference no. 5.1.7
	Consult instructions for use	Indicates the need for the user to consult the instructions for use	ISO 15223-1:2016 Reference no. 5.4.3
	Temperature limit for storage in the dark	Indicates the temperature limits to which the product can be safely exposed, and that the product must be kept in the dark until use	Modified from ISO 15223-1:2016
	Research use only	Indicates that a product is intended for research use; not for use in diagnostic procedures	21 CFR 809.10 (c) (i)
	Good manufacturing practice	Indicates that the product is manufactured according to quality system requirements	21 CFR 820 ISO 13485:2016
	Analyte specific reagent	Caution: Analytical and performance characteristics are not established	21 CFR 809 (e)
	Custom Solution & Service	Developed and/or manufactured according to customer specifications	Immudex generated symbol
	Storage temperature	Indicates the temperature to which the product should be stored	Modified from ISO 15223-1:2016
	Keep cool at all times	Indicates the temperature to which the product should be kept at all time	Immudex generated symbol
	Prescription use only	Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner	21 CFR 801.109

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