The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer. The EmbryoSlide+ ic8 dish has 8 culture wells,…
The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer. The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release. The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
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 EmbryoSlide+ ic8 dish | 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 |
| 510(k) | K213869 |
| Record published | 2022-08-20 |
| Record revised | 2026-04-27 (version 3) |
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, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Cardboard box of 40 |
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.