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This device is restricted to be sold to and used by licensed healthcare practitioners for assisted reproduction procedures in a clinical laboratory setting.
Polyvinylpyrrolidone (PVP) with HSA - 7% is a viscous solution that allows for easier sperm micromanipulation by slowing or immobilizing sperm for intracytoplasmic sperm injection (ICSI). PVP 7% has relatively less viscosity than PVP 10% and is recommended for use with low quality or low motility sperm. PVP solution also yields greater control over fluid flow and prevents sticking in the ICSI pipette.
Contains human serum albumin (5 mg/mL) and reconstituted in isotonic HEPES-buffered HTF medium.
CE Marked
Quality Control Testing:
Endotoxin by Limulus Amebocyte Lysate (LAL)
Sterility by the current USP, CFR and Ph. Eur. Sterility Test
Sperm Motility Recovery Assay
Sperm motility after exposure to PVP was comparable to control medium without PVP after one hour.
