FDA Master File

Enables incorporation of ThawSTAR® into clinical studies MAF on file with FDA (reference number MAF2643) containing information on all models of ThawSTAR the Master File for ThawSTAR®Automated Cell Thawing System has been registered to the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) under the reference number MAF2643. If you are submitting an investigational new drug (IND) application or a biologics license application (BLA) to the U.S. FDA, and need a cross-reference letter to our Master File, please contact us at regulatory@medcision.com.

 

FDA Master File Acceptance for ThawSTAR Cell Thawing Instrument

MedCision [BioCision] Announces FDA Master File Acceptance for ThawSTAR Automated Cell Thawing Instrument