The BIRR IVF Labware has been developed and produced according to the highest quality standards. All our tests are being performed in a state of the Art laboratory, which strives for continuous improvement on the quality of their tests. This enables BIRR to ensure that labware products are being tested against the highest standards.

BIRR introduces its smART Labware label:
BIRR IVF labware with innovative feature and added value on ease of use or safety versus conventional labware

CE Mark: Class IIa sterile Medical Device according 93/42 EEC Directive

Certification:

  • ISO 13485: 2016 certified,
  • FDA cleared,
  • Registered in various countries. When required, local regulatory registration will be established

Results per LOT number available:

Mouse Embryo Analysis (MEA): Across the Labware portfolio two different type of MEA tests are being performed the Standard MEA or Extended MEA

  • The Standard MEA is being performed on the labware that has contact time <24 hours with gametes, embryos, sperm
  • The Extended MEA is being performed on labware that has a contact time >24 hours, done for all dishes

Sperm Motility Assay (SMA): Our standard read out time is set on 8 hours and must be above >0.75 sperm motility index (SMI). The majority of IVF process will fall within the <8 hours range.

Limulus amebocyte lysate (LAL): all portfolio has been tested with LAL