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Update IFU Spermac Stain and VitalScreen, MSDS EpiScreen Plus (18-FEB-2019)
The instructions for use of Spermac Stain and VitalScreen have been updated.

The changes are listed in detail in the two statements which can be downloaded below:
IFU update notification - Spermac Stain
IFU update notification - VitalScreen

Click here to visit the Spermac Stain product page and download the latest version of the instructions for use.
Click here to visit the VitalScreen product page and download the latest version of the instructions for use.

Furthermore, the MSDS of EpiScreen Plus was updated and now includes the update of the GMDN code.
Click here to visit the EpiScreen Plus product page and download the latest version of the MSDS.

FertiCult IVF medium CE marked! (21-DEC-2018)
We are proud to announce that FertiCult IVF medium has been approved by our Notified Body (DEKRA Certification – 0344) and is now CE-marked! FertiCult IVF medium is a bicarbonate buffered cell culture medium for fertilization by IVF or ICSI. The CE marked product does not contain insulin and the composition of this medium fulfills the needs of gametes in preparation of, and during fertilization.

The instructions for use and the MSDS of FertiCult IVF medium have been updated. Click here to visit the FertiCult IVF medium product page and download the latest version of the instructions for use or MSDS.

Update IFU SpermFreeze and 10% PVP in Flushing (25-OCT-2018)
The instructions for use of SpermFreeze and 10% PVP in FertiCult Flushing medium have been updated.

The changes are listed in detail in the two statements which can be downloaded below:

  • IFU update notification - SpermFreeze
  • IFU update notification - 10% PVP in FertiCult Flushing medium

  • Click here to visit the SpermFreeze product page and download the latest version of the instructions for use.
    Click here to visit the 10% PVP in FertiCult Flushing medium product page and download the latest version of the instructions for use.

    LeucoScreen Plus, renewal certificates, update IFU SpermMar, MSDS IVDs (11-OCT-2018)

    *new* LeucoScreen Plus
    LeucoScreen Plus is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. LeucoScreen Plus has an equal capability to distinguish between peroxidase-positive and -negative round cells as the LeucoScreen kit (same assay performance), but has the advantage that the substrate is not carcinogenic.
    Click here to visit the LeucoScreen Plus product page, watch the instruction video and download the instructions for use, MSDS and excel training file.

    Renewal quality management certificates and CE certificates
    FertiPro’s quality management certificates (ISO 13485:2016, ISO 9001:2015 and MDSAP) and CE certificates have been renewed! Click here to download the ISO 9001/ISO 13485 certificate and ISO 13485 MDSAP certificates. CE certificates are available upon request.

    Update IFU SpermMar Test IgG/IgA
    The IFU of SpermMar Test IgG/IgA has been updated. What has changed? The SpermMar Test IgG Negative Control should yield less than 40% spermatozoa covered with latex particles instead of 20% or less spermatozoa covered with latex particles. This change is in line with the stated positive cut-off value of 40%. Furthermore, some other minor changes have been made to the text in the IFU.
    Click here or here to visit the SpermMar Test IgG or SpermMar Test IgA product page and download the latest version of the instructions for use.

    Update Material Safety Datasheets (MSDS) of IVDs
    The MSDSs of SpermMar Test IgG, SpermMar Test IgA, Citric Acid Test, Fructose Test, Spermac Stain, LeucoScreen, VitalScreen, HOS Test and FertilitySCORE have been adapted to include an update of the GMDN codes. The MSDSs can be found per product page on our website.

    Update IFU LeucoScreen and SpermMar Test IgG/IgA (10-SEP-2018)
    The instructions for use of LeucoScreen and SpermMar Test IgA and IgG have been updated.

    The update of the instructions for use of LeucoScreen includes a small change with a new barcode for the product demonstration video and the addition of a calculation method for samples with undetermined total round cell concentration.
    Click here to visit the LeucoScreen product page and download the latest version of the instructions for use.

    The update of the instructions for use of SpermMar Test IgA/IgG is the addition of the barcode to view the product demonstration video. Further cervical mucus is omitted as a specimen type from the IFU of SpermMar Test IgG.
    Click here or here to visit the SpermMar Test IgG or SpermMar Test IgA product page and download the latest version of the instructions for use.

    Update IFU HOS Test and LeucoScreen (05-JUN-2018)
    The instructions for use of the HOS Test and LeucoScreen have been updated.

    The update of the instructions for use of the HOS Test includes small changes to the text describing the method.
    Click here to visit the HOS Test product page and download the latest version of the instructions for use.

    The update of the instructions for use of LeucoScreen includes a simplification of the current protocol.
    Click here to visit the LeucoScreen product page and download the latest version of the instructions for use.

    Update IFU FertiCult IVF medium (01-JUN-2018)
    The instructions for use for FertiCult IVF medium has been updated.

    FertiPro adapted the Mouse Embryo Assay protocol used to test FertiCult IVF medium before release. With this new protocol, mouse oocytes are inseminated in vitro with sperm in FertiCult IVF medium and after 2PN check, the zygotes are transfered to standard medium for 96-hours. The product is only released when the percentage of 1-cell to expanded blastocyst within 96 hours is higher or equal to 80%.

    Click here to visit the FertiCult IVF medium product page and download the latest version of the instructions for use.

    Update IFU FertiCult Mineral Oil (23-MAY-2018)
    The instructions for use for FertiCult Mineral Oil have been updated.

  • The instructions for use of FertiCult Mineral Oil now include 5 languages (English, French, German, Spanish and Italian).
  • The new IFU indicate that additional storage temperatures between 2-15°C are also allowed. Stability data have demonstrated that FertiCult Mineral Oil can also be stored at 2-8°C when it is not possible to store at room temperature (15-25°C). However, be aware that this might cause some turbidity which disappears when the oil is warmed up again.
  • Furthermore, the endotoxin specification is narrowed from <0.25 EU/ml to <0.1 EU/ml.
  • The product codes for Mineral Oil in PETG bottles were also added.
  • Finally, the update also includes some extra advice provided in the section ‘instructions for use’.

  • Click here to visit the FertiCult Mineral Oil product page and download the latest version of the instructions for use.

    *NEW* Sil-Select Plus density gradients with Human Serum Albumin ! (16-MAY-2018)

    Based on the results of clinical evaluation and validation studies, we have found out that the performance of our current formulation of Sil-Select Plus can be improved by addition of a small concentration of human albumin solution. The main advantage is the reduced unintended adhesion of spermatozoa to laboratory glass ware whilst handling. For many years, embryologists have been preparing density gradient layers by diluting Sil-Select Stock solution with FertiCult Flushing medium, which contains 4 g/Liter Human Serum Albumin.

    We want to serve you to the best of our abilities and manufacture ready-to-use Sil-Select Plus containing a small concentration of Human Serum Albumin (< 2.5 g/Liter). This change will not affect the intended use and have no consequences for the protocol.

    Click here to visit the Sil-Select Plus product page, download the latest version of the instructions for use and MSDS.

    Update IFU (13-APR-2018)
    The instructions for use for FertiCult Aspiration medium, Hyaluronidase in FertiCult Flushing medium and VitriFreeze/VitriThaw have been updated.

    The update of the instructions for use of FertiCult Aspiration medium only includes minor changes.
    Click here to visit the FertiCult Aspiration medium product page and download the latest version of the instructions for use.

    The update of the instructions for use of Hyaluronidase in FertiCult Flushing medium only includes minor changes.
    Click here to visit the Hyaluronidase in FertiCult Flushing medium product page and download the latest version of the instructions for use.

    The update of the instructions for use of VitriFreeze/VitriThaw includes small changes. Additional information was included in the text describing the method. Furthermore, the instructions for use now specifies the number of procedures that can be performed.
    Click here to visit the VitriFreeze/VitriThaw product page and download the latest version of the instructions for use.

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