|
|
CE Marked (CE 0086)
AG90-050, 50 ml
AG90-100, 100 ml |
Indications for Use |
|
For the removal of dead sperm, debris, and other cells from human sperm cells prior to in vitro fertilization and ICSI. |
|
|
|
Storage and Shelf Life |
|
Store at 2-8°C and protected from light. Two (2) years from the date of manufacture.
|
|
|
|
Composition |
|
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 |
|
|
|
|
|
Quality Control Specifications |
|
Assay (performed for each batch) |
Specification |
pH (at room temperature in air) |
7.2-7.6 |
Osmolality |
300-320 mOsM |
Specific Gravity |
1.1050-1.1150 g/ml |
Viscosity (25°C) |
< 1.65 cP |
Endotoxin (LAL) |
< 1.0 EU/ml |
Sterility Test (bacterial and fungal screen, SAL 10–3) |
PASS |
Sperm Survival Test (survival after 4 h) |
> 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 AllGrad® 90% 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® 90% 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.
|