Falcon® IVF Certified Dishes
Falcon® IVF plasticware is designed to help you achieve normal growth and development, and ultimately, successful results with your highly sensitive IVF and reproductive applications. The innovative, consistent, and reliable dishes and well plates feature a sterile, flat, optically clear, single-use device designed to control heat transfer for temperature stability and for optimum manipulation and observation of ova and embryos while you work.
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.
- Tissue culture (TC)-treated for a consistent hydrophilic surface
- Sterilized by gamma irradiation (SAL 10-6)
- Flat dish bottoms for distortion-free optics
- Packaged in peel-open, medical-style packaging
- Multi-unit bags have reseal tabs
Pre-tested plasticware for in vitro fertilization (IVF)
CE marked to the Medical Device Directive 93/42/EEC
Manufactured in accordance with FDA Quality System Regulation
US FDA-cleared Class II medical device. Specially designed for IVF and other assisted reproduction applications
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 develop- ment, 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
The unique lid design of the IVF plate (Cat. No. 353654) reduces the risk of contamination and minimizes evaporation by providing access to two wells at a time, while two remain covered. The wells are numbered and a large writing patch allows clear sample identification. Plates are packaged in individual peel-open trays for sterile presentation. The Falcon IVF lids are designed for aseptic manipulation and consistent venting to maintain humidification (except the tight- fit lid of the Falcon low-wall dish).
The Falcon low-wall dish has many of the same features as the other IVF products, except the dish is non-tissue culture (TC)-treated (non-wettable), for optimal media droplet consistency. The Falcon low-wall dish also makes the micromanipulation procedure easier to perform. This product is packaged in individually sealed blister compartments so one dish can be accessed at a time, and the remaining dishes are kept protected. Procedures requiring long term incubation are not recommended in the Falcon low-wall dish due to the tight lid fit, which results in low gas exchange rates.
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.
|Mfr. No. 353652
||60mm TC-Treated In Vitro Fertilization (IVF) Dish, 20/Pack, Sterile, 500/Case.
|Mfr. No. 353653
||Falcon® 60mm Center Well IVF/Organ Culture Dish,TC-treated, certified nonembryotoxic polystyrene, 20/pack, Sterile, 500/case.
|Mfr. No. 353654
||4 Well TC-Treated In Vitro Fertilization (IVF) Plate, Individually Wrapped, Sterile, 100/Case.
|Mfr. No. 353655
||50mm x 9mm Not TC-Treated In Vitro Fertilization (IVF)/Low Wall Dish, 4Pack, Sterile, 100/Case