Product Sheets | Vitrification Brochure - Irvine Scientific
Product Sheets | Vitrification Brochure - Irvine Scientific
Product Sheets | Vitrification Brochure - Irvine Scientific
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Quality Testing<br />
Each lot receives a complete laboratory evaluation<br />
including mouse embryo testing, endotoxin level,<br />
pH, osmolality and sterility testing. All results are<br />
provided in a lot-specific Certificate of Analysis.<br />
<strong>Irvine</strong> <strong>Scientific</strong>’s commitment to excellence<br />
is demonstrated by its products’ performance<br />
and adherence to the industry’s highest quality<br />
standards. <strong>Irvine</strong> <strong>Scientific</strong> was the first ART<br />
manufacturing company in the USA to receive<br />
ISO 13485:2003 quality systems certification, the<br />
rigorous international quality assurance standard<br />
designed specifically for Medical Devices.<br />
<strong>Product</strong>s manufactured by <strong>Irvine</strong> <strong>Scientific</strong> are<br />
produced in accordance with the Guidelines for<br />
Manufacture of In Vitro Diagnostic <strong>Product</strong>s and<br />
the Good Manufacturing Practices (GMPs) for<br />
Medical Devices.<br />
References<br />
1. Conaghan et al., (2010), Human blastocyst <strong>Vitrification</strong> and<br />
Warming: 3 Years Experience Using the CryoTip®<br />
2. Tucker M, Liebermann J, (2007), <strong>Vitrification</strong> in Assisted<br />
Reproduction. United Kingdom. Informa Healthcare<br />
3. Smith et al., (2010), Prospective randomized comparison of human oocytes cryopreservation<br />
with slow-rate freezing or vitrification, Fertility and Sterility, Feb 18 2010<br />
4. Cobo et al., (2008), Effect of different cryopreservation protocols on the metaphase II<br />
spindle in human oocytes, Reproductive BioMedicine Online, Volume 17, 16 July<br />
5. Kartberg A-J et al., (2008), <strong>Vitrification</strong> with DMSO protects embryo membrane integrity better<br />
than solution without DMSO, Reproductive BioMedicine Online, Volume 17, 3 September<br />
6. Data on file.<br />
7. Data on file.<br />
North America Headquarters<br />
<strong>Irvine</strong> <strong>Scientific</strong><br />
2511 Daimler Street, Santa Ana, CA 92705<br />
USA<br />
Phone: 1 (949) 261-7800<br />
Toll Free: 1 (800) 437-5706<br />
Fax: 1 (949) 261-6522<br />
www.irvinesci.com<br />
2012 <strong>Irvine</strong> <strong>Scientific</strong> P/N 10034R Rev.11<br />
Europe Headquarters<br />
<strong>Irvine</strong> <strong>Scientific</strong><br />
Unit 31, Newton Business Center, Block D<br />
Newtownmountkennedy<br />
County Wicklow<br />
Ireland<br />
Phone: +353 1 281 99 20<br />
Fax: +353 1 281 99 28<br />
Asia Headquarters<br />
<strong>Irvine</strong> <strong>Scientific</strong><br />
3-17-35 Niizo-Minami<br />
Toda-Shi<br />
335-0026 Saitama<br />
Japan
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