Product Change Notifications
For your convenience, Product Change Notifications (PCN) will be available on DNA Genotek's website. This will provide you with immediate access to all product change notifications, as they are published.
PD-PCN-00087: DNA Genotek has appointed Novosanis NV as EU Authorized Representative, effective July 1, 2023.
We are making this transition to streamline our regulatory processes and better support our customers with CE-marked products. Device labeling will change from Emergo Europe to Novosanis NV.
PD-PCN-00085: The U.S. Food and Drug Administration (FDA) has granted a general use 510(k) clearance for the ORAcollect•Dx family of products. DNA Genotek will be updating the product labeling to reflect an expanded intended use statement, which now includes over-the-counter (i.e., direct-to-consumer) use.
PD-PCN-00083: DNA Genotek will discontinue the sale of the MO-3 bio-specimen bag as of April 29 due to supply chain constraints. After this date, the MO-3 will no longer be available for purchase. However, we are pleased to offer you alternate bio-specimen bags to ensure you can continue shipping your collected samples safely.
PD-PCN-00073: DNA Genotek recently completed planned real-time shelf-life testing for the ORAcollect-RNA collection devices. As a result the pre-collection self-life of ORAcollect-RNA collection device has been extended from 12 months to 24 months when stored at room temperature.
PD-PCN-00069: ORAcollect•Dx devices are transitioning to a multi-language IFU to support customers who are using these products in the European Union and require compliance with the European Union Medical Device Regulation (EU MDR)
PD-PCN-00042: ORAcollect•Dx, ORAcollect•Dna and ORAcollect for pediatrics for collection of human DNA (OCD-100, OCD-100A, OCR-100 and OC-175). Changes to the digit serial number and digit product code. Click to read the pdf document.
PD-PCN-00041: The Oragene•RNA (RE-100) vial collection kit is changing to a tube format which optimizes collection, transport and extraction. As such, the RE-100 vial format is no longer available for sale. The new Oragene•RNA mailable tube format is currently available and is designed to yield equivalent RNA results to the original RE-100 vial format.
PD-PCN-00039: Oragene•DNA (OG-250) and Oragene•DISCOVER (OGR-250) disc format pre-collection storage instructions are changing from 15°C – 30°C to 15°C – 25°C. Additionally, the product shelf-life is changing from 30 months to 24 months from date of manufacture.
PD-PCN-00030: Based upon user feedback and DNA Genotek’s continued commitment to manufacturing easy-to-use products, we have made the human readable barcode larger and easier to read on our ORAcollect® for pediatrics product.
PD-PCN-00023: ORAcollect is being rebranded to ORAcollect•Dx to coincide with receipt of 510(k) clearance from the United States Food and Drug Administration (FDA). ORAcollect•Dx was cleared by the FDA as a class II IVD medical device (K152464) on May 26, 2016.
PD-PCN-00022: DNA Genotek is implementing a UDI on all Oragene•Dx collection devices. The UDI will be a 2D data matrix (5mm x 5mm) located on the collection tube label. DNA Genotek's Global Trade Item Number (GTIN) which is embedded within the UDI also appears on the tube label in human-readable format. The existing 128C barcode on the tube label is not affected by this change and should continue to be used for sample traceability.
PD-PCN-00020: DNA Genotek will be changing the brand name and labelling of our OMNIgene•DISCOVER products to OMNIgene•ORAL. Note that the product catalog numbers will remain the same (OM-501 and OM-505).
PD-PCN-00019: Based upon user feedback and DNA Genotek’s continued commitment to quality, DNA Genotek has made improvements to our tube label. We will be aligning the date format with international standards, growing the label whitespace panel and repositioning label content to create additional writable whitespace. Additionally, the height of the machine readable barcode will be standardized to 7 mm and the font size on the human readable portion of the barcode will increase, making it easier to read.
PD-PCN-00017: Based upon user feedback and DNA Genotek’s continued commitment to quality, DNA Genotek has made improvements to our tube label. We will be aligning the date format with international standards, growing the label whitespace panel and repositioning label content to create additional writable whitespace. For products containing barcodes, the height of the machine readable barcode will be standardized to 7 mm and the font size on the human readable portion of the barcode will increase, making it easier to read.
PD-PCN-00016: Based upon user feedback, DNA Genotek has made an improvement to the OMNIgene•GUT (OMR-200) product. The wooden stick in the collection kit will be replaced with a plastic spatula. This replacement is an esthetic improvement and does not affect the overall performance of the kit.
PD-PCN-00013: Based upon user feedback, DNA Genotek has made improvements to our ORAcollect (OC-100) product. We will be changing the double-ended cap and the collection tube dimensions to improve kit handling and compatibility with liquid automation platforms.
PD-PCN-00012: DNA Genotek is standardizing their animal products into one platform, therefore Oragene®•ANIMAL (OA-400) will be discontinued and the Performagene•LIVESTOCK (PG-100) name will change to PERFORMAgene.
PD-PCN-00010: DNA Genotek will continue to provide prepIT•L2P manual purification reagents complementary with purchases of Oragene and/or ORAcollect DNA collection product lines until August 31, 2011. Orders placed after this date will be subject to individual product charges.
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