Items, CFDA SPEC., MEDIROLL^®

Items	CFDA SPEC.	MEDIROLL®
Cytotoxicity	< 0.25 EU/㎖	0.25 EU/㎖
Sensitization test	There must not be hypersensitivity reaction	Appropriate
Acute systemic toxicity test	There must not be acute systemic toxicity	Appropriate
Hematolysis test	≤ 5.0%	3.8 %

Biological reaction test (USP CLASS Ⅵ)

• USP range toxicity test: Appropriate
• USP intradermal capacity test : Appropriate
• USP muscle graft test : Appropriate
• Cytoclasis : Appropriate
• USP pyrogenicity test : Appropriate
• USP hematolysis test : Appropriate