Immudex Symbols

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)
Storage temperature Indicates the temperature to which the product should be stored Modified from ISO 15223-1:2016
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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