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CE Marked (CE 0086)
AG45-050, 50 ml
AG45-100, 100 ml |
| Indications for Use |
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For the removal of dead sperm, debris, and other cells from human sperm cells prior to in vitro fertilization and ICSI. |
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| Storage and Shelf Life |
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Store at 2-8°C and protected from light. Two (2) years from the date of manufacture.
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| Composition |
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Silane-coated silica particles in an aqueous solution containing:
Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Potassium Phosphate, Sodium Bicarbonate, HEPES, Glucose, Sodium Pyruvate, Sodium Lactate, EDTA |
| Instructions for Use |
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| Quality Control Specifications |
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| Assay (performed for each batch) |
Specification |
| pH (at room temperature in air) |
7.2-7.6 |
| Osmolality |
290-310 mOsM |
| Endotoxin (LAL) |
< 1.0 EU/ml |
| Sterility Test (bacterial and fungal screen, SAL 10–3) |
PASS |
| Sperm Survival Test (survival after 4 h) |
> 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 AllGrad® 45% for the removal of dead sperm, debris, and other cells from human sperm cells prior to in-vitro fertilization and ICSI.
- 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
- AllGrad® 45% contain only a low concentration of sodium bicarbonate and should not be gassed with CO2.
- To avoid problems with contamination, practice aseptic techniques.
- Once the bottle is opened, store the product tightly capped at 2-8°C and protected from light.
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Link to AllGrad® 45%IFU