The USA Standard
All donors or specimens that meet Cryos' USA-Standard are selected, screened and comply with all regulation in force in United States of America - see:
Title 21--Food and Drugs - CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 1271
HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
FDA-regulation came into force on 25MAY2005. Ejaculates donated before this date are not governed by the regulaton and the USA Standard. Ejaculates donated before that day may be released by USA Standard, but not necessarey, however, they are always released according to the DK Standard.
There is a ban on import to USA from following countries for ejaculates donated after 25MAY2005:
Appendix 5: List of BSA-Affected Countries Applicable to Donor Deferral:
Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Liechtenstein, Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, United Kingdom1, and Yugoslavia.
1For purposes of this guidance, the United Kingdom should include all of the following: England, Northern Ireland, Scotland, Wales, the Isle of Man, the Channel Islands, Gibraltar, and the Falkland Islands
Cryos International - New York, LLC are licensed by FDA.
Cryos International - Denmark ApS are licensed by FDA.
See other Standards.