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CE Marked (CE 0086)
LGPO-100, 100 ml
LGPO-500, 500 ml
AMPO-100, 100 ml (Amber Bottle) |
| Indications for Use |
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An oil overlay for droplets of medium for embryo culture or manipulation. |
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| Storage and Shelf Life |
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Store at 15-25°C and protected from light. Two (2) years from the date of manufacture. |
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| Composition |
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A pharmaceutical grade light paraffin oil, pre-washed with water. |
| Instructions for Use |
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| Quality Control Specifications |
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| Assay (performed for each batch) |
Specification |
| 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: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using LiteOil®.
- 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
- To avoid problems with contamination, practice aseptic techniques.
- Once the bottle is opened, store the product tightly capped at 15-25°C and protected from light.
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Link to Paraffin Oil P.G. IFU