HTF w/ HEPES

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HTF w/ HEPES

HTF w/ HEPES  
CE Marked (CE 0086)

GMHH-100, 100 ml
GMHH-250, 250 ml
GMHH-500, 500 ml

Indications for Use   For handling, washing & manipulation of embryos & oocytes.
     
Storage and Shelf Life   Store at 2-8°C and protected from light. Fourteen (14) weeks from the date of manufacture.
     
Composition   A HEPES-buffered medium is required when gametes and embryos are handled outside of a CO2 incubator.

Sodium Chloride, Potassium Chloride, Calcium Chloride, Potassium Phosphate, Magnesium Sulfate, Sodium Bicarbonate, Glucose, Lactate Na Salt, Sodium Pyruvate, Phenol Red, HEPES, Gentamicin Sulfate* (10 μg/ml), *from therapeutic-grade source material
Instructions for Use  

Link to HTF w/ HEPES IFU

     
Quality Control Specifications  
Assay (performed for each batch) Specification
pH 7.2-7.4
Osmolality 280-292 mOsM
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  
  1. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
  2. Caution:Caution: The user should read and understand the Instructions for Use, Precautions and Warnings, and be trained in the correct procedure before using the HTF w/ HEPES for retrieval of human oocytes).
  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. HTF w/ HEPES contains the antibiotic gentamicin sulfate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
  7. HTF w/ HEPES contains only a low concentration of sodium bicarbonate and should not be gassed, or used for culture under CO2.
  8. To avoid problems with contamination, practice aseptic techniques.
  9. Discard unused medium within 7 days of opening. Do not use after expiry date.