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| Product Description |
CytoSinct CD34 Nanobeads, human (GMP) is intended for the in vitro magnetic labeling for pre-separation or other processing of human CD34 positive cells from heterogeneous cell populations enabling further cultivation and/or genetic modification of the cells. |
| Capacity |
Up to 6x108
target cells from up to 6x1010 total cells |
| Composition |
Colloidal solution of iron-dextran nanobeads conjugated to monoclonal CD34 antibody in PBS buffer stabilized with HSA and Poloxamer 188 |
| Endotoxin Content |
< 2 EU/mL as determined by Limulus Amebocyte Lysate (LAL) limit assay (USP <85>) |
| Sterility |
Sterility is tested and confirmed according to USP <71> |
| Storage |
Store at 2-8°C |
| Disclaimer |
CytoSinct CD34 Nanobeads, human (GMP) is for ex vivo cell processing only, and are not intended for human in vivo applications. It is designed following the recommendations of USP <1043> on ancillary materials and the Guidance for CMC Research and Evaluation of Immune Cell Therapy Products (Trial Implementation) published by the National Medical Products Administration in China. It is manufactured and tested according to relevant GMP guidelines. |
| Warranty |
The products sold hereunder are warranted only to be free from defects in workmanship and material at the time of delivery to the customer. GenScript makes no warranty or representation, either expressed or implied, with respect to the fitness of a product for a particular purpose. There are no warranties, expressed or implied, which extend beyond the Specification of the products. Gen Script's liability is limited to either replacement of the products or refund of the purchase price. GenScript is not liable for any property damage, personal injury, or economic loss caused by the product. |
| Warnings and precautions |
1. Do not freeze. 2. The product is intended for in vitro use only. Not for intravenous infusion. 3. Any clinical application of the separated cells is exclusively within the responsibility of the user. 4. Do not use after the expiry date printed on the product label. 5. Do not use it if the package is damaged. Use reagent only if the vial is undamaged and sealed. 6. Do not reuse. 7. The product is not recommended for use with patients known or suspected to have sensitivity against mouse immunoglobulins or iron-dextran. 8. Patients may develop human anti-mouse antibodies (HAMA). |
