Falcon® 4-well TC-treated in vitro Fertilization (IVF) Dish (353671)
Falcon® 4-well in vitro Fertilization (IVF) dish with single lid is comprised of nonembryotoxic, noncytotoxic, TC-treated polystyrene. Individually wrapped, sterile, 100/case. Well area: 1.39 cm², Well Volume: 1.8 mL. 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.
- TC-treated for a consistent hydrophilic surface
- Sterilized by gamma irradiation
- Packaged in peel-open, medical-style packaging
- Multi-unit bags have reseal tabs.
- Qualified plasticware for in vitro fertilization (IVF) and assisted reproduction techniques
- US Food and Drug Administration (FDA) cleared Class II medical device
- Manufactured in accordance with FDA Quality System Regulation 21 CFR Part 820 (cGMP)
- CE marked in compliance with the European Medical Devices Directive 93/42/EEC
- Manufactured under EN ISO 13485 quality standards
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.
Our innovative Falcon® IVF plasticware designs feature a sterile, flat, optically clear, single-use device for optimum manipulation and observation of ova and embryos. Falcon IVF dishes and four-well plates are designed to control heat transfer, keeping temperatures stable while you work.
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.
|| 1 / Pk
|| 100 / Cs
|Cell Growth Area
|| 1.39 cm²
|| 1.8 mL
|Well Bottom Color
|Mfr. No. 353671
||4 Well TC-Treated In Vitro Fertilization (IVF) Dish, Single Lid, Individually Wrapped, Sterile, 100/Case.