| Size | Catalog Id | Availability |
|---|---|---|
| 50 mL | CCD1-050 | In Stock |
| Available for sale in the USA, Canada, and select countries. | ||
CaseBio™ Culture
Product Description:
CaseBio™ Culture is a next-generation embryo culture medium designed to support consistent development from fertilization through the blastocyst stage. Formulated with a bicarbonate buffer system, it is intended for use in environments with controlled CO₂ concentrations to maintain optimal physiological conditions. CaseBio™ Culture is not for injection. The clinical benefit of the product arises from creating an optimal environment that supports the development of viable embryos, as evidenced by improved implantation and clinical pregnancy rates.
CaseBio™ Culture requires supplementation with human serum albumin or another suitable protein, as per standard laboratory protocols. The formulation does not include a protein supplement and contains Gentamicin.
Intended Use
CaseBio™ Culture is intended for the culture of embryos from fertilization to the blastocyst stage. It is also suitable for the transfer of embryos to the uterus. Intended for use during in-vitro ART procedures.
Key Features
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High-quality, medical-grade raw materials screened for every incoming batch
Traceability and documentation maintained from source to final product
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Triple QC testing on each lot
Stringent quality control to include pH, osmolality, endotoxin LAL, sterility, and One-Cell MEA with ≥80% embryos developed to expanded blastocysts at 120 hours.
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Sterile filtered and sterility tested in compliance with USP<71> standards
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Manufactured under a strict Quality Management System (ISO 13485:2016 certified manufacturer)
Quality system aligned with international standards for medical device manufacturing
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FDA-registered manufacturing facility
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MDSAP certified
Certified to meet regulatory requirements across multiple global markets
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Reliable batch-to-batch consistency through rigorous quality control system and controlled processes
Controlled processes ensure reproducibility and dependable results. Certificates of Analysis provided with every lot.
Specifications:
| Product Line | CaseBio™ |
| Indications for Use/Intended Use | CaseBio™ Culture is used for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus. Intended for use during in-vitro ART procedures. |
| Classification | Class II medical device, FDA-cleared and registered with Health Canada |
| Form | Liquid |
| Shelf Life | 90 days from date of manufacture |
| Sterility | Sterile-filtered |
| Storage Conditions | 2-8°C. Protect from light |
| Shipping Condition | Cold Chain |
| Manufacturing Quality | ISO 13485:2016 certified and aligned with international standards for medical device manufacturing |
