Newcyte-FX

About The Product

Stem cells obtained from the amniotic fluid have recently become an interesting alternate source of pluripotent stem cells for therapeutic applications. Similar to embryonic stem cells, amniotic fluid stem cells are clonogenic and have the capacity to differentiate into cells of the endoderm, mesoderm and ectoderm lineages.

Product name	Proprietary name(Brand name)	Specifications
Amniotic Fluid Stem cell Complex (Extracellular Fluid Substance) (Volume sizes: 1 ml, 2ml, 3ml, 4ml)	Newcyte-FX	• Homologous use only • Allogeneic • Rich source of Stem cell. • Code of federal regulations: HCT/Ps 21 CFR 1271.3(c) • Frozen at -86 Celsius. • Donor eligibility: -Extensively Serologically tested for multiple infectious diseases/agents. Please refer to Certificate of analysis for list of infectious diseases panel we test every cord tissue. – Donor Medical history, physical assessment, behavior assessment review by a medical director before the batch release. • The Donor eligibility determines by a Medical director by reviewing -Behavioral risk assessment • Product integrity, quality and sterility are our only priorities. • Amniotic Fluid will be received from an official registered Cord blood/Tissue bank. • For Therapeutics purposes only. • Rich source of different type of Stem Cells-Mostly Pre-mature. (Usually less than Cord blood/Cord Tissue/Amniotic Tissue).-Usually supplemented with Stemell Cord Blood/tissue stem cells products. • Rich source of nutrients and antibodies (cells in the body that fight off infection) • Disease testing report will be provided to the Medical/Health care professional. • FDA REGISTERED • HIPAA Registered • Public Health Registered

Quality Control Specifications	Test*	Specification
	Sterility (fungi, yeast, bacteria)	No growth
	Mycoplasma contamination	None detected
	pH	7.5 ± 0.05
	Osmolality	276 ±10 mOsm/Kg
	Cell culture test	Linear signal across a 1000-fold range of cells
	*Please consult the Certificate of Analysis for lot-specific test results
Functional Testing	Newcyte is performance tested to generate a linear fluorescent signal across a 1000-fold range of adherent mammalian cells.

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