Среды и наборы сред вспомогательных для репродуктивных технологий: среда Bromelain in Dulbecco´s PBS

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Gynemed GmbH & Co., KG, ГЕРМАНИЯ

класс:

изделия медицинского назначения

Производитель:

Gynemed GmbH & Co.

Дата Авторизация:

2022-04-22

Характеристики продукта

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