GM508 CultActive
GM508 CultActive is a bicarbonate-buffered reagent designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles.
GM508 CultActive is designed to investigate if fertilization failure after previous ICSI-cycles is due to a deficient oocyte activation.
Rev03_00
| Product description | Product code | Unit |
|---|---|---|
| CultActive | 4 GM 508CULT-active1 | 1 ml |
Product facts and notices
- Composition
- Product specifications and quality control
- Instructions for use
- Precautions and warnings
- Storage instructions and stability
Composition:
- NaCl, KCl, KH2PO4, MgSO4.7H2O, NaHCO3, CaCl2.2H2O, D(+)-Glucose anhydrous, Na-Lactate, Na-Pyruvate, EDTA, Alanyl-Glutamine, water, non-essential and essential Amino Acids, DMSO, Ca2+-Ionophore A23187.
Product specifications and quality control:
- All raw materials are of highest available purity (European Pharmacopoeia 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 GM508 CultActive is available upon request and can be downloaded from our website.
- GM508 CultActive is manufactured and tested according to the following specifications:
| pH (at 37°C, 6 % CO2) | 7,00-7,60 |
| Osmolality (mOsm/kg) | 400-450 |
| Sterility | sterile – SAL 10-3 (Sterility Assurance Level) |
| Endotoxins (EU/ml) | < 0,25 |
| MEA (Blastocysts after 96 h in %) | ≥ 80 |
Instructions for use:
- GM508 CultActive must be shaken directly before use for approximately 30 sec.
- GM508 CultActive must be equilibrated 4 hours in a vial not firmly closed at 5-7 % CO2 and 37°C prior to use.
- Equilibrate culture medium for washing (e.g. GM501 Cult) for 4 hours in a vial not firmly closed at 5-7 % CO2 and 37°C prior to use.
- Prepare for each oocyte 1 drop (30 µl) GM508 CultActive and 2 drops (30-50 µl) MOPS- and HEPES-free culture medium, (e.g. GM501 Cult). An oil overlay is not necessary due to the short exposure time.
- Immediately after the ICSI procedure incubate the oocytes for 15 minutes in the pre-equilibrated Ca2+-Ionophore GM508 CultActive drops. -Step 1
- Remove the oocytes from the GM508 CultActive drop and wash them twice in culture media. This has to be done in a HEPES-or MOPS-free medium, e.g. GM501 Cult. -Step 2 and 3
- Put the oocytes in your culture media for further culture.
- Assess the development on specific time points.
Precautions and warnings:
- Handle all specimens as if capable of transmitting HIV or hepatitis. Always wear protective clothing when handling specimens.
- Product does not contain any antibiotics. Always work under strict hygienic conditions (e.g. LAF-bench, ISO Class 5) to avoid possible contamination.
- Only for the intended use.
Pre-use checks:
- Do not use the product if bottle, seal of the container or package is opened or defective when the product is delivered.
- Do not use the product if it becomes discoloured, cloudy or shows any evidence of microbial contamination.
Storage instructions and stability:
- Shelf life is 6 months from time of manufacture.
- Store between 2-8 °C.
- Do not freeze before use.
- Keep away from (sun)light.
- The product can be used safely up to 7 days after opening, when sterile conditions are maintained and the products are stored at 2-8°C.
- Do not use after expiry date.