 |
|
CE Marked (CE 0086)
LGUA-100, 100 ml
LGUA-500, 500 ml
AMLG-100, 100 ml (Amber Bottle) |
| Indications for Use |
|
An oil overlay for droplets of medium for embryo culture or manipulation. |
| |
|
|
| Storage and Shelf Life |
|
Store at 15-25°C and protected from light. Two (2) years from the date of manufacture.
|
| |
|
|
| Composition |
|
A pharmaceutical grade quality mineral oil. |
| Instructions for Use |
|
|
| |
|
|
| Quality Control Specifications |
|
| 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% |
|
| |
|
|
| Precautions and Warnings |
|
- 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.
|
Link to LifeGuard® Oil IFU