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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-103 ( download pdf ): Oragene™•Dx (OGD-575, OGD-675) devices will undergo labeling changes.

PD-PCN-102 ( download pdf ): The Oragene™•DISCOVER (OGR-500, OGR-600, OGR-575, OGR-675) and Oragene™•Dx (OGD-500, OGD-510, OGD-600, OGD-610) devices will undergo labeling changes.

PD-PCN-Colli-Pee ( download pdf ): Effective December 8th, 2024, DNA Genotek™ will be the Legal Manufacturer of the Colli-Pee™ product family.

PD-PCN-101 ( download pdf ): The ORAcollect™•Dx (OCD-100, OCD-100A) and ORAcollect™•DNA (OCR-100) devices are undergoing changes to their regulatory labeling and packaging.

PD-PCN-100 ( download pdf ): The OMNIgene™•GUT, OMNImet™•GUT, (OMR-200, ME-200) and PERFORMAbiome•GUT (PB-200) devices are undergoing changes for plastic cap product components.

PD-PCN-98 ( download pdf ):The ORAcollect™•RNA (ORE-100) device and packaging will undergo the changes and labeling change from EUA to RUO.

PD-PCN-97 ( download pdf ): ORAcollect RNA labeling change from EUA to RUO.

PD-PCN-96 ( download pdf ): DNA Genotek Inc. is updating the product labeling and Instructions for Use (IFU) for the affected products to include the new Authorized Representative (AR) information for Europe, Switzerland and the United Kingdom.

PD-PCN-95 ( download pdf ): DNA Genotek is qualifying the Bethlehem, PA manufacturing site of its parent company, OraSure Technologies, Inc., to produce all DNA Genotek products.

PD-PCN-93 ( download pdf ): Oragene™•DNA devices will be replaced with the equivalent Oragene™•Dx saliva collection devices.

PD-PCN-00091 ( download pdf ): As part of DNA Genotek's continuous improvement process, tube/cap and label change are being made to the OMNIgene™•ORAL, OMNIgene™•SKIN and OMNIgene™•VAGINAL product lines.

PD-PCN-00092: OMR-205 shelf-life extension to 18 months.

PD-PCN-00090: DNA Genotek is changing the SKU reference of the OMNIgene•GUT and accessories collection kit configurations:

OMR-200+ACP101 is changing to MP-018

OM-200+ACP102 is changing to MP-017

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-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-00070: ORAcollect•RNA ORE-100 kits in May 2020, were temporarily switched from manufacturing with a red double-ended cap to ORE-100.025 kits (with a blue double-ended cap). Starting in May 2021, we are switching back to manufacturing ORE-100 kits (with a red double-ended cap).

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-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-00034: ORAcollect•DNA 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-00032: 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®•DNA product.

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-00025: Based upon user feedback and additional performance data, DNA Genotek has made improvements to our OMNIgene•GUT product.

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-00018: 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-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-00014: Based upon user feedback, DNA Genotek has made improvements to our ORAcollect DNA (OCR-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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