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Product dating information statement sigma

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This commitment is demonstrated by the establishment of programs to monitor, preserve and protect the quality of our products. We document the Quality Release Date, that is, the point in time when analytical data has been reviewed as confirming compliance with product description, specification and lot uniformity, for all products. For those materials where shelf life information is a requirement, expiration and retest periods are available at the batch level.

IVD products that are expiration dated will have the expiration date found on the product labels. When dating is indicated by month and year only and no specific date is otherwise stated on the label or elsewhere, the product is expected to meet specifications until the last day of the month. The Recommended Retest Date for individual lots may be extended subject to quality review. Expiration Dated Products Products in the expiration date program will have an Expiration Date printed on the label and the Certificate of Analysis.

The batch should not be used after this date.

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Summative Re-test Ticket retest. The Recommended Retest Date for individual lots may be extended subject to quality review. Every attempt will be made, subject to available inventory, to satisfy these requests. Should customers need products to be supplied with specific minimum remaining expiration or re-test time, this should be communicated at the time of order entry. This blocking time is batch specific. The Quality Release Date is the point in time when analytical data has been reviewed as confirming compliance with product description, specification and lot uniformity.

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