PD-PCN-107 ( download pdf ): DNA Genotek has extended the shelf life of all OMNIgene™•OMR-1XX devices, including ORAL, VAGINAL, and SKIN, from 15 to 24 months.

PD-PCN-106 ( download pdf ): We are transitioning our reagent protocols/instructions for use (IFU) printed paper to a convenient digital format. The prepIT™ and OMNIgene™ Liquifaction reagent labeling will be updated to include the https://www.dnagenotek.com/ed/ URL to access the procotols.

PD-PCN-105 ( download pdf ): DNA Genotek is updating the OMNIgene™·GUT (OMR-205) devices with new plastic caps and reduced weights.

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)