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CE Marked (CE 0086)
LGFR-100, 100 ml
LGFR-500, 500 ml |
| Indications for Use |
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For human oocyte retrieval and washing outside of a CO2 incubator. |
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| Storage and Shelf Life |
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Store at 2-8°C and protected from light. Fourteen (14) weeks from the date of manufacture. |
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| Composition |
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A HEPES-buffered medium is required when gametes and embryos are handled outside of a CO2 incubator.
Sodium Chloride, Potassium Chloride, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Lactate Na Salt, Sodium Pyruvate, Phenol Red, HEPES, 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 |
7.2-7.4 |
| Osmolality |
280-292 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% |
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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: Caution:The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using the Washing mHTF w/ HEPES & Phenol Red when handling gametes and embryos outside a CO2 incubator.
- 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
- Washing mHTF w/ HEPES & Phenol Red contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- Washing mHTF w/ HEPES & Phenol Red contains only a low concentration of sodium bicarbonate and should not be gassed, or used for culture under CO2.
- To avoid problems with contamination, practice aseptic techniques and discard minimal amounts of excess medium remaining in the bottle.
- Discard unused medium within 7 days of opening.
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Link to Washing mHTF w/ HEPES & Phenol Red IFU