PCR ComfortLids Instructions for Use (IFU)
Intended Use
The PCR ComfortLids are consumables intended for use in an in vitro diagnostic environment to seal the PCR plates to prevent evaporation and contamination.
You can download the Instructions for Use (IFU) in multiple languages above. Additional languages are available upon request.
Transport and Storage
The PCR ComfortLids are sealed in a blister and packed in a cardboard box. They are therefore protected against moisture and transport damage.
- Transport: The product must be transported at temperatures between -15 °C (+5 °F) and +55 °C (+131 °F) up to a maximum of 90 days. This is indicated on the secondary label (cardboard box).
- Storage: The product must be stored at temperatures between 0 °C (+32 °F) to +35 °C (+95 °F) until expiration. This is indicated on the primary label (blister).
- Short-term temperature peaks: Up to +55 °C (+131 °F) for a maximum of 90 days and storage up to +45 °C (+113 °F) for up to one year at any point during the product shelf-life period are validated and do not affect product integrity.
- Relative Humidity: Not required.
Purity Grade
The PCR ComfortLids are produced in a Cleanroom (ISO Class 8) and are free of Pyrogens, RNAse, DNAse, PCR Inhibitors, Human DNA, and ATP. With the packaging format described above, it is ensured that the Hamilton PCR ComfortLids maintain their Purity Grade status during both transport and storage.
Sterility
The PCR ComfortLids are treated with ethylene oxide (EO). This is indicated on the primary and secondary labels. On the secondary label is an indicator that turns green after treatment.
Shelf Life
The PCR ComfortLids have a shelf life of 5 years after the date of production. The shelf life is indicated on the primary and secondary labels. After the removal of the sealed film, the shelf life remains unchanged, but the purity of the product can no longer be guaranteed. It is recommended to perform a visual inspection for damage to packaging before use and to remove the blister lid just before use.
Disposal
The PCR ComfortLids are intended for single use
Legal Aspects
Hamilton Company and Hamilton Bonaduz AG are the legal manufacturers of the Hamilton PCR ComfortLids, all rights reserved. This Instructions for Use (IFU) document may not be used or reproduced in any way whatsoever without the express written consent of Hamilton Company or Hamilton Bonaduz AG.
Note
Any serious incident or near-incident that has occurred in relation to the consumables shall be reported to Hamilton and to the competent authority of the Member State in which the operator is established.
Contact Hamilton either by contacting a local Hamilton representative or by utilizing Hamilton’s webpage, which can be found on the footer of this document.
If you have questions on our other consumable products, such as reservoirs, plates, tubes, sealing consumables, and waste consumables, please visit our website under this link:
https://www.hamiltoncompany.com/consumables-labware-accessories
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