iGeneTech Bioscience Co., Ltd.
EN

Quality & Safety

Quality Management System

iGeneTech Bioscience has obtained ISO 9001:2015 quality management system certification and ISO 13485:2016 medical device quality management system certification and implements a strict internal quality management system to ensure that product quality meets standards and is stable.


iso9001           iso13485

Labels & Symbols

Labels on the boxes, tubes and bottles.

Examples of box labels
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Examples of tube/bottle labels
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Symbols

Symbols and words on the labels

Symbol

Title

Description

Qty

Quantity

The number of reactions or nominal volume of the kit according to the IFU

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Manufacture

Name and address of the manufacturer

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Catalog Number

The catalog code of the manufacturer to identify the product

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Batch Number

The batch code of the manufacturer to identify a group of products

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Serial Number

The serial number of the manufacturer to identify a specific product

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Use-by Date

Represents a date that cannot be used after that date. The date is written as YYYY-MM-DD

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Upper limit of temperature

The upper temperature limit of the environment to which the product can be safely exposed

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Limit of temperature

The temperature range of the environment to which the product can be safely exposed

Panel Name

Panel Name

A simple name that allows users to distinguish different panels

Panel ID

Panel Unique ID

The unique number of a complete Panel


SDS
Click to add item number