Fertipro NV

Address:INDUSTRIE PARK NOORD 32,BEERNEM West-Vlaanderen,BE

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Device Description : VitriThaw™ Thawing 3 (REF: VT3001) (3 ml) Component of VitriThaw™ kit, which ar VitriThaw™ Thawing 3 (REF: VT3001) (3 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) .For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which ar VitriThaw™ Thawing 4 (REF: VT4001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) .For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Device Description : SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of SPMG_A and SPMG_L.The SpermMar Test IgG is a diagnostic kit for detecting antisperm antibodies of the IgG class in human semen or serum. The direct SpermMar Test IgG can be performed on untreated human semen provided it contains motile spermatozoa, the indirect SpermMar Test IgG can be used on serum. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction.More information can be found at the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : KTO

Prescription Use : No

Device Count : 1

Device Description : SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies and consists of SPMG_A and SPMG_L.The SpermMar Test IgG is a diagnostic kit for detecting antisperm antibodies of the IgG class in human semen or serum. The direct SpermMar Test IgG can be performed on untreated human semen provided it contains motile spermatozoa, the indirect SpermMar Test IgG can be used on serum. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction.More information can be found at the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : KTO

Prescription Use : No

Device Count : 1

Device Description : SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class.The Spermar Test IgA is a diagnostic kit for detecting antisperm antibodies of the IgA class in human semen. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction.More information can be found at the FertiPro website: www.fertipro.com

Device Class :

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : KTO

Prescription Use : No

Device Count : 1

Device Description : LeucoScreen Plus™ is an improved histochemical staining kit for the determinatio LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. 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. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen).For more information, visit the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1

Device Description : LeucoScreen Plus™ is an improved histochemical staining kit for the determinatio LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. 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. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). For more information, visit the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1

Device Description : LeucoScreen Plus™ is an improved histochemical staining kit for the determinatio LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. 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. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). For more information, visit the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1

Device Description : LeucoScreen Plus™ is an improved histochemical staining kit for the determinatio LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. 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. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). For more information, visit the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1

Device Description : LeucoScreen Plus™ is an improved histochemical staining kit for the determinatio LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. 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. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). For more information, visit the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1