+27 83 208 9766      info@nanomedsa.co.za

VitriFreeze ES TM / VitriThaw ESTM

Intended use

VitriFreeze ES™ / VitriThaw ES™ are a set of media for vitrification and thawing of human embryos (zygote till expanded blastocyst stage).

VitriFreeze ES™ / VitriThaw ES™ are ready-to-use.

Composition

VitriFreeze ES™ / VitriThaw ES™ contain PBS and human serum albumin (11-20 g/l depending on the individual medium, medicinal substance derived from human blood plasma). None of the media contain antibiotics. VitriFreeze ES™ media have increasing concentrations of DMSO and ethylene glycol (EG). VitriFreeze ES™ Freezing 3 also contains sucrose and Ficoll. VitriThaw ES™ media have decreasing concentrations of sucrose.

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 codes

VF_KIT1_ES : VitriFreeze ES™ kit
VT_KIT1_ES : VitriThaw ES™ kit

pH 7.2-7.4
Osmolality VitriFreeze ES™ Pre-incubation medium : 270-295mOsm/kg (release criteria: 270-290mOsm/kg)
VitriThaw ES™ Thawing medium 2: 805-865mOsm/kg (release criteria: 805-850mOsm/kg)
VitriThaw ES™ Thawing medium 3: 535-565mOsm/kg
VitriThaw ES™ Thawing medium 4: 405-435mOsm/kg
VitriThaw ES™ Thawing medium 5: 270-295mOsm/kg (release criteria: 270-290mOsm/kg)
Sterility test by the current Ph. Eur. 2.6.1/ USP <71> No growth
Endotoxin < 0.25 EU/mL
Mouse embryo assay (% blastocysts after 96 hours, after sequential exposure to freezing and thawing media) ≥ 80%
Shelf life 12 months from date of production

VitriFreeze ESTM and VitriThaw ESTM media are sets of cell culture media designed for the vitrification of 2PN up to blastocyst stage human embryos.

Instructions For Use

Summary of safety and clinical performance

Material Safety Data Sheet