Hyaluronidase in FertiCultTM Flushing medium

Intended use
Hyaluronidase in FertiCult™ Flushing medium is used in the oocyte denudation process in preparation of intracytoplasmic sperm injection (ICSI) or other Assisted Reproductive Technologies. Hyaluronidase digests the hyaluronic acid between the cumulus cells, which makes it easier to remove the cumulus mechanically.

Hyaluronidase in FertiCult™ Flushing medium is ready-to-use.

Composition
Hyaluronidase in FertiCult™ Flushing medium is a HEPES-buffered medium which also contains bicarbonate, physiologic salts, glucose, lactate, pyruvate, human serum albumin (4.0g/l, medicinal substance derived from human blood plasma) and 80 IU/ml hyaluronidase from bovine origin.

Further information on the composition of the medium can be found in the material safety data sheet.

Regulatory

  • Europe: CE-marked (MDR, Notified Body number 2797)
  • Brazil: Registered
  • Other regions: Information available upon request

Product order codes

HYA001 : 5x 1ml Hyaluronidase in FertiCult™ Flushing medium
HYA010 : 1x 10ml Hyaluronidase in FertiCult™ Flushing medium

pH 7.30-7.90 (7.30-7.60 at product release)
Osmolality 270-290 mOsm/kg
Sterility test by the current Ph. Eur. 2.6.1./ USP <71> No growth
Endotoxin < 0.5 EU/mL
Concentration human serum albumin 3.2-4.8 g/L
Mouse embryo assay (% blastocysts at 96 hours, after 30 minutes exposure to test medium) ≥ 80%
Shelf life 12 months from date of production

Oocyte

Hyaluronidase in FertiCult Flushing medium is a ready-to-use cell culture medium for oocyte denudation

Instructions For Use
Summary of safety and clinical performance
Material Safety Data Sheet