Falcon® 4-well TC-treated in vitro Fertilization (IVF) Plate (353654)

Falcon® 4-well in vitro Fertilization (IVF) Plate is comprised of non-embryotoxic, non-cytotoxic, 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.

Non-embryotoxic
nonpyrogenic
Non-cytotoxic
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

More on Falcon IVF Products

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.

The 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.

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.

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.

Performance Tested

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

Embryotoxicity

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.

Sterility

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.

Nonpyrogenic

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.

Cytotoxicity

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.

Quality Certificate

Brochure

Product Number	353654
Qty./Pk	1 / Pk
Qty./CS	100 / Cs
Brand	Falcon®
Plate Format	4-well
Plate Color	Clear
Well Bottom Color	Clear
Well Shape	Round
Cell Growth Area	1.39 cm²
Recommended Medium Well Volume	1.8 mL
Surface Treatment	TC-Treated
Sterile	Yes

Lot Number Lookup

To look up a lot number for a Falcon item, click the above link and enter your Product Number and Lot number under the Quality Certificate Lookup.

Specifications:

Mfr. No. 353654

4 Well TC-Treated In Vitro Fertilization (IVF) Plate, Individually Wrapped, Sterile, 100/Case.

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