Falcon® 60 mm TC-treated Center Well in vitro Fertilization (IVF)/Organ Culture Dish (353653)
Falcon in vitro Fertilization (IVF) products are the first plasticware available that is sterile, nonpyrogenic and nonembryotoxic. These qualified products save you time and expense in complying with the College of American Pathologists (CAP) and American Fertility Society (AFS) recommended standards for IVF labs.
Falcon IVF products were designed and created in partnership with embryologists, to ensure safe and reliable products for sophisticated IVF and other assisted reproduction applications.
- Well Area: 2.45 cm² , Well Volume: 2.5 mL, Total Volume: 20 mL
- Nonembryotoxic, nonpyrogenic, and noncytotoxic
- Tissue culture-treated for a consistent hydrophilic surface
- Sterilized by gamma irradiation
- Packaged in peel-open, medical-style packaging - Multi-unit bags have reseal tabs
Due to the sensitive nature of in vitro fertilization (IVF) work, you must have precise, consistent, and highly reliable products that are designed to help you achieve normal growth and development, and ultimately, successful results.
Certified and Tested
Pre-tested Falcon® IVF products were the first plasticware available certified sterile, nonpyrogenic, noncytotoxic, and nonembryotoxic. These pre-tested products save you time and expense in complying with the College of American Pathologists and the American Society for Reproductive Medicine recommended standards for IVF labs.
Each lot of Falcon IVF product is subjected to a performance test for growth with a mammalian cell line. A minimum of 90% confluency within 72 hours is required for lot acceptance.
Quality Management and Control
Falcon IVF products are manufactured in compliance with the current version of the EN ISO 9001 Standard, the EN ISO 13485 Standard, the Medical Device Directive (MDD) 93/42/EEC as amended with 2007/47/EEC, and the FDA CFR 21 Part 820 and current Good Manufacturing Practices (cGMP).
Medical Device Classification
◗ US FDA 510(k) cleared Class II medical device
◗ CE marked in compliance with the European Medical Devices Directive 93/42/EEC as Class IIa medical device
Each lot of Falcon IVF product is tested for embryotoxicity using the one-cell mouse embryo assay. A minimum of 75%, of both test and control embryos, must reach the hatched and/ or expanded blastocyst stage in order for our products to be deemed nonembryotoxic and acceptable for product release.
Falcon IVF products are irradiated and dosimetrically released per the requirements of ANSI/ AAMI/ISO 11137 and meet a minimum Sterility Assurance Level (SAL) of 10-6.
Each lot of Falcon IVF product is tested and meets the criteria established in the United States Pharmacopeia (USP) Chapter <85>, “Bacterial Endotoxins Test.” The acceptance level for a product is less than 0.1 EU/mL or 5 EU/device.
Thorough testing is conducted to qualify material resins to USP Class VI. Products are also tested and qualify as noncytotoxic per the requirements of ISO 10993-5, Biological evaluation of medical devices – Tests for in vitro cytotoxicity.
Genotoxicity, Carcinogenicity, and Reproductive Toxicity
Products have been tested and demonstrated to be non-mutagenic and non-genotoxic per the requirements of ISO 10993-3, Biological evaluation of medical devices: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
Individual certificates, containing actual test results, are available for each lot by contacting your local Corning Life Sciences office after you receive your order.
|| 20 / Pk
|| 500 / Cs
|Mfr. No. 353653
||Falcon® 60mm Center Well IVF/Organ Culture Dish,TC-treated, certified nonembryotoxic polystyrene, 20/pack, Sterile, 500/case.