Država: Bjelorusija
Jezik: ruski
Izvor: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Gynemed GmbH & Co., KG, ГЕРМАНИЯ
изделия медицинского назначения
Gynemed GmbH & Co.
2022-04-22
BROMELAIN IN DULBECCO´S PBS GYNEMED MATERIAL INCLUDED IN THE PACKAGE: Bromelain in Dulbecco´s PBS Product code: 4 GM 501BROM10 • 1 x10 ml Bromelain in Dulbecco´s PBS MATERIAL NOT INCLUDED IN THE PACKAGE: • Incubator (no CO 2 ) • Sperm Cup • LAF bench (ISO 5 environment) • Microscope • Test tubes PRODUCT SPECIFICATIONS AND QUALITY CONTROL: • All raw materials are of highest available purity (European Pharmaco- poeia and/or USP standard) if applicable. • A certificate of analysis is available for each batch upon request from our website with respective lot number. • The MSDS for Bromelain in Dulbecco´s PBS is available upon request and can also be downloaded from our website. • Bromelain in Dulbecco´s PBS is manufactured and tested according to the following specifications: pH (at 37°C) 7.20-7.50 Osmolality (mOsm/kg) 270-290 Sterility sterile - SAL10 -3 (Sterility Assurance Level) Endotoxins (EU/ml) < 0.5 Mouse Embryo Assay (MEA) ≥80 (1-cell assay, blastocysts after 96 h in %) Sperm Survival test ≥80 survival after 4 hours exposure of density selected spermatozoa to the test medium in % EN: INTENDED USE/INTENDED USERS: • Bromelain in Dulbecco‘s PBS is designed for liquefaction of viscous semen samples prior to semen analysis and preparation for further IVF treatment. • The intended users are IVF professionals (lab technicians, embryolo - gists or medical doctors). COMPOSITION: • Bromelain solved in Dulbecco’s PBS • Bromelain in Dulbecco’s PBS is an enzyme preparation and has a spe - cific activity of 10 IU/ml. INSTRUCTIONS FOR USE: • Warm the Bromelain in Dulbecco‘s PBS to 37°C. • Dilute the semen sample with the same volume of Bromelain (for highly viscous, tenacious ejaculate we recommend to previously grind the ejaculate roughly!) • Swing the semen solution carefully • Incubate the ejaculate for approx. 10 minutes at 37°C. • Use the liquefied semen sample for evaluation. Attention: To calculate the sperm concentration the dilution 1+1 (1:2) of semen with Pročitajte cijeli dokument