The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to…
The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture. The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6). Indications for Use / Intended Use: For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Who Else Makes It
Concentrated in Guangdong (8), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Micro well group culture dish, 16-well | Listed by | Vitrolife A/S, Denmark |
| FDA product code | MQK |
| Device type | Labware, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2017-09-21 |
| Record revised | 2026-04-27 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 8 to 25 °C |
| Packaging | Card board box of 10 |
| Distribution end date | 2026-04-15 |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.