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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-00086: The Oragene 600 series cap design has been implemented to support improved moulding capacity and product inventory

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-00084: The OMNIgene®•GUT and accessories collection kit is changing. A new SKU will be assigned and the MO-3 biospecimen bag will be discontinued

PD-PCN-00081: The purple cap of the OMNIgene®•GUT collection devices (OMR-200) will no longer features the DNA Genotek name.

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-00072: OMNIgene products OMR-1XX are undergoing a label change.

PD-PCN-00071: DNA Genotek has discontinued production of the SO-1 sample storage box.

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-00059: ORAcollect RNA labelling to support use under Emergency Use Authorization (EUA)

PD-PCN-00066: As of March 31, 2021, we will be discontinuing OGR-250 and OG-250 Oragene saliva collection kits as well as the CS-1 and CS-2 accessories for assisted collection.

PD-PCN-00061: OMNIgene•ORAL (OME-505) saliva collection device will temporarily be manufactured with collarless tubes and light blue

PD-PCN-00062: As of January 1, 2021, the OME-505 will be the designated product to fulfill orders of OMNIgene•ORAL for use in COVID-19 testing.

PD-PCN-00060: MO-A and MO-B mailing solutions are no longer approved for shipping exempt human specimen samples and exempt animal specimen samples by the United States Postal Service (USPS).

PD-PCN-00046: “Made in Canada” has been removed from our OMNIgene•GUT and PERFORMAbiome•GUT tyveks and instructions for use (IFUs).

PD-PCN-00058: The OMNIgene® collection tube devices (OMR-110, OMR-120, OMR-130 and OMR-140) will no longer come individually packaged.

PD-PCN-00048: ORAcollect products undergoing a barcode structure change to the 1D 128C barcode.

PD-PCN-00049: Performagene (PG-100) products are undergoing changes which include: packaging dimensions, barcode structure, storage temperature and shelf-life.

PD-PCN-00054: ORAcollect RNA kits will be manufactured with blue D/E caps, not red.

PD-PCN-00051: Adding over-the-counter (OTC) use indication and general clearance to the OGD family of devices

PD-PCN-00053: Barcode addition to the tube label for the OMNIgene•ORAL (saliva) OM-501 and OM-505

PD-PCN-00052: Barcode addition and product name “MMB collection tube” change for the OMNIgene•ORAL (gum/plaque and tongue) and OMNIgene•VAGINAL

PD-PCN-00045: The product shelf life of Oragene.DX saliva collection devices (OGD 600,610,675 and OGD 500,510,575) is increasing from 24 months to 30 months from date of manufacture.

PD-PCN-00043: Performagene for collection of animal DNA samples (PG-100). Changes to the digit serial number and digit product code. Click to read the pdf document.

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-00036: DNA Genotek will be discontinuing the manufacture and sale of the prepIT•MAX (PT-MAX) extraction kit. This product will be available until July 2017.

PD-PCN-00031: DNA Genotek has updated the MO-A in accordance with the International Air Transport Association (IATA) regulations.

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-00027: 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.

PD-PCN-00024: Based upon user feedback and additional performance data, DNA Genotek has made improvements to our OMNIgene•GUT 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-00011: DNA Genotek has changed the brand name and labeling of our Oragene•DNA product within the United States for our academic research customers to Oragene•DISCOVER.

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.

PD-PCN-00009: DNA Genotek will be changing the color of the Oragene•ANIMAL transport and purification tube caps from teal and purple to clear and red, respectively.

PD-PCN-00008: DNA Genotek has changed the name of the OG-L2P purifier to prepIT•L2P and has applied a new brand treatment to the labeling.

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DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease applications. The Company's Oragene•Dx and ORAcollect•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries.

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