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CE Marked (CE 0086)
GMHT-100, 100 ml
GMHT-250, 250 ml
GMHT-500, 500 ml |
| Indications for Use |
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Culture of cleavage-stage human embryos (Day 1 to Day 3). |
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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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A bicarbonate-buffered medium replete with glucose, lactate, and pyruvate is required to support the growth and development of human embryos in vitro.
Sodium Chloride, Potassium Chloride, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Lactate Na Salt, Sodium Pyruvate, Phenol Red, Gentamicin Sulfate* (10 μg/ml), *from therapeutic-grade source material
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| Instructions for Use |
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| Quality Control Specifications |
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| Assay (performed for each batch) |
Specification |
| Physicochemical Tests |
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| pH (with 5% CO2) |
7.2-7.4 |
| Osmolality |
280-292 mOsM |
| Biological Tests |
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| Endotoxin (LAL) |
< 0.5 EU/ml |
| Sterility Test (bacterial and fungal screen, SAL 10–3) |
PASS |
| Biological Assays |
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| 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 HTF. 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
HTF. |
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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 the HTF for the Culture of cleavage-stage human embryos (Day 1-3).
- 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
- HTF 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 HTF IFU