Среды культуральные и изделия вспомогательные для экстракорпорального оплодотворения (ЭКО): среда GM508 CultActive

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

GM501 MINERAL OIL
GYNEMED
MATERIAL INCLUDED IN THE PACKAGE:
Product code: 4 MO 0100
•
1 x 100 ml GM501 Mineral Oil
Product code: 4 MO 0500
•
1 x 500 ml GM501 Mineral Oil
MATERIAL NOT INCLUDED IN THE PACKAGE:
•
Incubator (at 37°C)
•
Petri-dishes
•
LAF bench (ISO 5 environment)
•
Microscope
•
Test tubes
•
Cell culture media
PRODUCT SPECIFICATIONS AND QUALITY CONTROL:
•
Pharmaceutical grade mineral (paraffin) oil.
•
A certificate of analysis is available for each batch upon request
from
our website with respective lot number.
•
The MSDS for GM501 Mineral Oil is available upon request and can
also be downloaded from our website.
•
GM501 Mineral Oil is manufactured and tested according to the follo-
wing specifications:
EN: INTENDED USE/INTENDED USERS:
•
GM501 Mineral Oil is a ready-to-use oil for covering the medium dur-
ing IVF/ICSI treatment. GM501 Mineral Oil protects the medium from
evaporation and thereby stabilizes pH and temperature.
•
The intended users are IVF professionals (lab technicians, embryolo-
gists or medical doctors).
COMPOSITION:
Mineral Oil
•
CAS code: 8042-47-5
•
EP Monograph: 0240
GENERAL INFORMATION:
•
GM501 Mineral Oil (density 0.83 - 0.86 g/ml) is pre-washed twice with
ultra-pure water. GM501 Mineral Oil has to be pre-incubated for 5
hours with the lid closed at 37°C
INSTRUCTIONS FOR USE:
•
GM501 Mineral Oil is a pre-washed ready-to-use oil, so no further pre-
parations are necessary.
•
After pre-incubation (5 hours/37°C) overlay the culture medium with
GM501 Mineral Oil until it is completely covered.
•
We recommend preparing the dishes with oil overlay the day before
use. If using bicarbonate buffered media incubate the dishes in a CO
2
incubator at 37°C to ensure warming and saturation with gas.
•
Any procedures described herein are recommendations only. Each
laboratory needs to establish and validate its own procedures for me-
dium preparation and use.
PRECAUTIONS AND WARNINGS:
•
Handle all specimens as if capable of transmitting HIV or hep