AllGrad® 90%

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AllGrad® 90%

AllGrad® 90%  
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  

Link to AllGrad® 90% IFU

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  
  1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  2. 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.
  3. Not to be used for injection.
  4. Devices are not intended for resterilization.
  5. 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
  6. AllGrad® 90% contain only a low concentration of sodium bicarbonate and should not be gassed with CO2.
  7. To avoid problems with contamination, practice aseptic techniques.
  8. Once the bottle is opened, store the product tightly capped at 2-8°C and protected from light.