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CE Marked (CE 0086)
LGGF-020, 20 ml
LGGF-050, 50 ml
LGGF-100, 100 ml
LGGF-500, 500 ml |
| Indications for Use |
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For holding human cumulus-oocyte complexes prior to IVF or ICSI and for conventional IVF. |
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| Storage and Shelf Life |
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Store at 2-8°C and protected from light. Ten (10) weeks from the date of manufacture. |
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| Composition |
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For fertilization to occur, a single sperm must pass through the cumulus cells, interact with the zona pellucida, fuse with the oolemma and decondense inside the ooplasm. The fertilization medium must meet the metabolic requirements of the sperm, cumulus cells, and oocyte.
Sodium Chloride, Potassium Chloride, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Lactate Na Salt, Sodium Pyruvate, Amino Acids, EDTA, Phenol Red, Gentamicin Sulfate* (10 μg/ml), *from therapeutic-grade source material |
| Instructions for Use |
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| Quality Control Specifications |
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| Assay (performed for each batch) |
Specification |
| pH (with 5% CO2) |
7.2-7.4 |
| Osmolality |
260-270 mOsM |
| Endotoxin (LAL) |
< 0.5 EU/ml |
| Sterility Test (bacterial and fungal screen, SAL 10–3) |
PASS |
| 1-cell Mouse Embryo Assay (% expanded blastocysts at 96 h of culture) |
> 80% |
| Special Note on the CO2 Concentration in the Incubator: In most cases, a 5-7% concentration of CO2 in the incubator will produce a pH of 7.2 to 7.4 in global® for Fertilization. However, the exact concentration of CO2 required to produce the optimum pH of approximately 7.30 (7.27-7.33) depends on several factors, including the physical characteristics of incubator and the altitude. Consequently, we strongly recommend that each laboratory determine and use the concentration of CO2 that is required to produce a pH of 7.30 in global® for Fertilization. |
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Precautions and Warnings |
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- Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
- Caution: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using global® for Fertilization for holding human cumulus-oocyte complexes prior to conventional in-vitro fertilization or ICSI, and for conventional in-vitro fertilization.
- Not to be used for injection.
- Devices are not intended for resterilization.
- Do not use the product if:
• the product packaging appears damaged or if the seal is broken
• the expiry date has been exceeded
• the product becomes discolored, cloudy, or shows evidence of particulate matter
- global® for Fertilization contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- To avoid problems with contamination, practice aseptic techniques.
- Discard unused medium within 7 days of opening. Do not use after expiry date.
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Link to global® for Fertilization IFU